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US: FDA "disapproves" of Wicked Lasers; stops imports

Tech website Gizmodo reports that the FDA’s Center for Devices and Radiological Health (CDRH) sent a letter Nov. 3 2010 to Wicked Lasers, disapproving of “the quality control and testing program for all [Wicked] laser products.” This includes the well-known Spyder III Arctic, a nominal 1-watt, 445 nm blue handheld laser.

FDA cites eight items of noncompliance:
  • Three of these items relate to a January 2006 letter which FDA says Wicked did not respond to.
  • Four items relate to Wicked claiming in 2006 and 2008 that its lasers were sold for surveying, leveling and alignment (SLA) purposes; FDA says Wicked is not complying with restrictions on SLA lasers. (FDA has greater authority to regulate SLA lasers than it does to regulate general-purpose lasers).
  • The final item objects to Wicked stating on its website that its products are “FDA Certified” when in fact the manufacturer certifies compliance to FDA, who reviews and files the certification documents.
FDA gave Wicked 15 days to respond in one of three ways: by refuting the charges, by requesting an exemption, or by notifying purchasers and taking corrective actions (e.g., a recall or refund). Wicked cannot certify lasers under the old “disapproved” testing program, and cannot import or sell non-compliant lasers or non-certified lasers.

The restrictions will be lifted, FDA told Wicked, once “CDRH determines that you have established an adequate quality testing program, and you have submitted the required reports and report supplements.”

Gizmodo. The full text of FDA’s warning letter to Wicked is after the link (click “Read more...”)
Below is text of a warning letter sent from FDA/CDRH to Wicked Lasers. The original letter is
here on FDA’s site.

Department of Health and Human Services

Public Health Service
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993

N0V 03, 2010

Ref: (b)(4)


Steve Liu, President
WickedLasers, Ltd.
23/F, One Island East
18 Westlands Road
Quarry Bay, Hong Kong

Xiao Pei Tao, President
Energy Technology Development Limited
Rm. 105, No.9, Lane 89
Anshun Rd
Shanghai, China 200050

Dear Messrs. Liu / Tao:

This letter notifies you that the United States' (U.S.) Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH) hereby disapproves the quality control and testing program for all laser products including, but not limited to model families Core, Spyder, Executive, Evolution, Elite, E2, E3, S3 and Pulsar produced by Energy Technology Development Limited, also known as Wicked Lasers, Ltd., Wicked Lights, Energy Tech Development Company, or Light Technology Group. This action is taken under the authority of the U.S. Federal Food, Drug, and Cosmetic Act (the Act), Chapter V, Subchapter C, Electronic Product Radiation Control, Section 534(h) [U.S.C. 360kk(h)].

This disapproval means that your firm is prohibited by Sections 534(h) and 538(a) of the Act from:

  1. Certifying electronic products manufactured under the disapproved testing program (§ 538(a)(5)(B)),
  2. Introducing, delivering for introduction, or importing into U.S. commerce any product which does not comply with the applicable standard (§ 538(a)(1)), and
  3. Introducing or importing into U.S. commerce any product which does not have a certification as required by section 534(h) and (§ 538(a)(5)(A)).
Items of noncompliance were discovered after reviewing our records containing your firm's product reports. Based on the findings listed below, CDRH finds that Energy Technology Development Limited, also known as Wicked Lasers, Ltd., Wicked Lights, Energy Tech Development Company, or Light Technology Group has failed to establish a quality test program which ensures compliance with the FDA regulations.

Specifically, the items of noncompliance include the following:
  1. 21 CFR 1002.10(d) Product reports - Describe the function, operational characteristics affecting radiation emissions, and intended and known uses of each model: The firm failed to properly identify its laser products as surveying, leveling, and alignment (SLA) lasers. This contradicts information contained in letters issued to the firm from CDRH dated January 12, 2006 and May 13, 2008 that identified the firm's laser products as SLA lasers.
  2. 21 CFR 1003.10 Discovery of defect or failure of compliance by manufacturer- notice requirements: The firm failed to respond to a letter dated January 12, 2006 that required notification of dealers/distributors of the violative products.
  3. 21 CFR 1003.11 Determination by Secretary that product fails to comply or has a defect: The firm failed to respond to a letter dated January 12, 2006 that required a written response to FDA with the number of referenced products that have been produced and number that have left the place of manufacture.
  4. 21 CFR 1004.1 Manufacturer's obligation to repair, replace, or refund cost of electronic products: The firm failed to submit a written corrective action plan for approval.
  5. 21 CFR 1010.4 Variances - The firm failed to apply for a variance from the performance standard for SLA products that exceed Class IlIa. A variance approval is necessary prior to the introduction of the laser product into commerce.
  6. 21 CFR 1040.11(b): The Class IIIb and IV products fail to comply with the class limits in § 1040.11(b) applicable to SLA laser products. Specifically, the Pro Series model families Spyder, Executive, Evolution, Sonar, Elite, EI, E2, E3, S1, S3 are Class IIIb or IV lasers that are limited to Class IIIa in the visible and Class I in the infrared or equivalent International Electrotechnical Commission (IEC) Classes 1, 2, or 3R.
  7. 21 CFR 1040.10(h)(1)(i) Informational requirements- User information: The firm's internet site at www.wickedlasers.com asserts its Class 3B and 4 laser products are not SLA laser products. This information contradicts information contained in letters issued to the firm dated January 12, 2006 and May 13, 2008 from CDRH that identified its Class IIIb Classic Series, Advanced Series, Extreme Series, Executive Series, Evolution Series, Elite Series, Signature Series, Photonic Disrutor, Spyder II GX, CORE Green Lasers; SONAR I Blu-ray, SONAR II Burner, Spyder II BX Blue Lasers; and Pulsar Series Red Lasers as SLA laser products.
  8. 21 CFR 1040.10(h)(1)(i) Informational requirements - User information: The firm's internet site at www.wickedlasers.com asserts its laser products are "FDA Certified". The manufacturer under 21 CFR 1010.2 is responsible for certification based upon a test or testing program, in accordance with the standard. The Firm's assertion that its laser products are certified by the FDA is a false certification.
You are required, under 21 CFR 1003.11(b), to immediately provide a written response to FDA with the number of laser products which have been produced and the number of such products that have left the place of manufacture. In addition, if the product distribution were confined to specific geographical areas of the United States, please specify those areas.

We request that you provide such a response no later than 15 days after receipt of this letter with one of the options listed below:
  1. Refutation. Under 21 CFR 1003.11(a)(3), you may submit your views and evidence to establish that the alleged failures to comply do not exist.
  2. Exemption Request. Under 21 CFR 1003.30(a), you may request an exemption from user and dealer/distributor notification requirements in Under 21 CFR 1003.10(b). You must respond within 15 days from receipt of this letter to apply for such an exemption. If exempted from such notification, you are not required to correct the violative products (under 21 CFR 1004.1 (a)). Your request must include the grounds upon which such exemption is requested (see 21 CFR 1003.30 and 1003.31) and the information required under 21 CFR 1003.20.
  3. Purchaser Notification and Corrective Action. If you neither refute the noncompliance nor request an exemption, then you must: (a) notify purchasers and dealers/distributors of the violative products as specified in 21 CFR 1003.10(b), and (b) submit a written corrective action plan (CAP) for approval showing how you will fulfill your obligation under 21 CFR 1004.1 to repair, replace, or refund the cost of the violative products.

  1. Notification Letter. Requirements for preparation of notification letters are prescribed in 21 CFR 1003.21 and 1003.22. A copy of the notification letter(s) sent to purchasers and dealers must also be sent to the FDA. It is recommended that you submit a draft of this letter to us for review.
  2. Corrective Action Plan. Instructions for preparation of a CAP may be found in 21 CFR 1004.2, 1004.3, or 1004.4. Such a plan must expeditiously correct the noncompliances and must be approved as set out in 21 CFR 1004.6.
If you request additional time to prepare your refutation, notification, CAP, or evidence to support a requested exemption, you must provide the reasons for any delays and a reasonable target date for the full submission of your response. Be aware that if an acceptable CAP cannot be prepared promptly, you may be required to proceed with interim notification to affected persons as required by 21 CFR 1003.11(c) and 1003.21. Therefore, you are encouraged to immediately begin your preparation of accurate user location lists.

Be advised that failure to respond to this letter may be considered to be a violation of section 538(a)(4) of the Act, 21 U.S.C. § 36000(a)(4). FDA is prepared to invoke regulatory actions if you fail to comply with these requirements. These actions may include an injunction and/or imposition of civil penalties as provided for in section 539 of the Act, 21 U.S.C. § 360pp.

Persons who violate section 538 of the Act are subject to civil penalties of up to $1,100 per violation and up to a maximum penalty of $355,000 without further notification by the FDA. In cases where a foreign manufacturer fails to respond, penalties may be imposed upon importers.

In summary, unless you decide to refute these allegations or request an exemption from dealer/distributors notification requirements, you must:
  1. Provide a list of all laser models manufactured and sold.
  2. Submit a supplemental report describing the quality control procedures you will use common to all production as found in 21 CFR 1002.30(a), with respect to electronic product radiation safety information. Model-specific quality control procedures must be submitted as separate supplemental reports, referencing the appropriate product report Accession number ((b)(4), (b)(4) and (b)(4)). This must be done so CDRH can determine that Energy Technology Development Limited is in compliance with the Act, that the subject products comply with the performance standard, and that the testing program is in accord with good manufacturing practices.
  3. Submit product reports for all laser products entered into US commerce including those listed in your firm's annual reports for which your firm has not already submitted product reports. Products must be identified by a name provided by your firm, not by the model name of a component or an uncertified laser product your firm purchased and modified. If model families exist for your products, list all laser products which belong to a model family for current and past production, and include this information in the supplemental reports mentioned in Item 2. Be advised that supplemental reports must also be submitted for those laser products within a model family which have changes in radiation emissions, affect the manner of compliance with a standard, or affect manner of testing for radiation safety from the base model.
  4. Submit a CAP which includes a procedure for performing the quality control procedures on all products sold to assure they comply with regulations found in 21 CFR 1010, 1040.10, and 1040.11. The CAP should address those deficiencies identified in this letter. In addition to being included in.the CAP, the informational requirement corrections must be included in the previously mentioned supplemental reports for the applicable product reports. Any discoveries of defect or failure to comply discovered during the execution of the CAP must be reported to CDRH immediately as per 21 CFR 1003.10.
  5. Notify all dealers, distributors, and purchasers of your Firm's failure to comply with FDA regulations for all of your firm's laser products. In accordance with 21 CFR 1003.21 Notification by the manufacturer to affected persons, your firm must also provide CDRH with copies of communications sent to purchasers, dealers or distributors in accordance with 21 CFR 1003.22.

The CDRH will advise you whether your CAP and requested information are satisfactory.

When you have completed any necessary production changes to assure compliance of future units, CDRH determines that you have established an adequate quality testing program, and you have submitted the required reports and report supplements, you may resume introduction of these products into commerce. Note, you must correct the noncompliances with an approved CAP for all sold products.

Copies of the Federal Performance Standards, compliance guides, radiation safety product report guides, and other documents related to laser products are available on FDA's web site at: http://www.fda.gov/Radiation-EmittingProducts/default.htm.

Your response should be sent to:

Chief, Electronic Products Branch
Division of Mammography Quality and Radiation Programs
Office of Communication, Education, and Radiation Programs
Center for Devices and Radiological Health
10903 New Hampshire Ave., WO66-4621
Silver Spring, Maryland 20993-0002

If you have any questions regarding the content of this letter, you may contact CAPT Dan Hewett, Health Promotion Officer at (301) 796-5864 or by internet electronic mail at Daniel.Hewett@fda.hhs.gov.

Sincerely yours,
Lynne L. Rice
Office of Communication, Education,
and Radiation Programs
Center for Devices and
Radiological Health