Inspections, Compliance, Enforcement, and Criminal Investigations
Wicked Lasers World Headquarter 12-Jan-06
Department of Health and Human Services
Public Health Service
Rockville, MD 20857
January 12, 2006
DELIVERY BY FEDERAL EXPRESS
Wicked Lasers World Headquarters
Room 108, No. 7, Lane 89 Anshun Rd.
This letter is written to advise you of items of noncompliance with the Classic 10 mW, Advanced, Extreme, and Elite lasers. The Food and Drug Administration (FDA) conducted a laboratory test at our Winchester Engineering and Analytical Center (WEAC) in Winchester, Massachusetts of a unit of your Beyond Extreme ELITE Equinox 105 milliwatt model. The unit tested at WEAC was ordered on November 25, 2005 and received there on December 5, 2005. The FDA is notifying you of the failure to meet the following requirements of the performance standard:
1. 21 CFR 1010.2 and 1010.3. The Elite model fails to have certification and identification labels.
2. 21 CFR 1040.10(f)(3). The Elite model lacks a remote interlock connector.
3. 21 CFR 1040.10(f)(4). The Elite model lacks a key control.
4. 21 CFR 1040.10(f)(5)(ii). The Elite model lacks an emission indicator with emission delay.
5. 21 CFR 1040. 10(f)(6). The Elite model lacks beam attenuators.
FDA also reviewed your Internet promotions for the Classic 10 mW, Advanced, Extreme and Elite Class IIIb laser system models. The specifications listed on the Internet for these models do not include specifications for the performance standards listed above in items 1-5 that we observed were not met in the Elite unit tested. Thus, it appears that the Classic 10 mW, Advanced, and Extreme models are not meeting required performance standards, as we observed with the Elite unit tested.
In addition, the brochure on the Internet for the Class IIIb laser system models fails to contain legible reproductions of the warning logotype labels for the models of green lasers. Therefore, such models do not meet the performance standard in 21 CFR 1040.10(h)(2)(i).
Sections 538(a)(1) and (a)(5) of the Federal Food, Drug, and Cosmetic Act (the Act)(21 U.S.C. 360oo(a)(1) and (a)(5), prohibit any manufacturer from introducing into commerce or certifying laser products, which do not comply with the applicable standards. Sections 538(a)(3) and (a)(4) of the Act (21 U.S.C. 360oo(a)(3) and (a)(4) prohibit any manufacturer from failing or refusing to establish and maintain required records or to submit required reports. Failure to respond to this letter may be considered to be a violation of Section 538(a)(4) of the Act. The Food and Drug Administration (FDA) is prepared to invoke regulatory actions if you fail to comply with these requirements. These actions may include an injunction and 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 $1,000 per violation, up to a maximum penalty of $300,000.
Under section 531(3) of the Act (21 U.S .C. 360hh(3)), a manufacturer includes any person engaged in the business of manufacturing, assembling or importing electronic products. Thus, in cases where a foreign manufacturer fails to respond, penalties may be imposed upon a person who imports the electronic products. We may commence regulatory action without giving you any additional notice.
You are required, under 21 CFR 1003.11(b), to immediately provide a written response to FDA with the number of the referenced products that have been produced and the number of such products that have left the place of manufacture. In addition, if the product distribution was 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 from receipt of this letter. In your response, we request that you respond.to one of the options listed below. Please note that you must respond within 15 days from receipt of this letter to apply for an exemption under option 2 (see 21 CFR 1003 .30(a)).
1. Refutation - Under 21 CFR 1003.11(a)(3), you may submit your views and evidence to establish that the alleged failures 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 21 CFR 1003.10(b). If exempted from such notification, you are not required to correct the violative products (21 CFR 1004.1(a)). Under 21 CFR 1003 .30(b), your request must include the information required by 21 CFR 1003.20 and set forth in detail the grounds upon which such exemption is sought .
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, as specified in 21 CFR 1003 .10(b), of the violative products; and (b) submit, as required by 21 CFR 1004.1(b), 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.
a. 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.
b . Corrective Action Plan - Instructions for preparation of a CAP may be found in 21 CFR 1004 .2, 1004.3, or 1004.4. Such plan must expeditiously correct the noncompliance(s) and must be approved by FDA 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 should 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 notification to affected persons as required by 21 CFR 1003.11(ac) and 1003.21.Therefore, you are encouraged to immediately begin your preparation of accurate user location lists.
In addition, we note your failure to comply with the following regulations regarding reports and record keeping:
1. 21 CFR 1002.10 Wicked Lasers has failed to submit product reports on any of its models of laser products, including the models referenced above.
2. 21 CFR 1002.13 Wicked Lasers has failed to submit annual reports on its laser products.
You are responsible for complying with all applicable statutory and regulatory requirements before these products are introduced, or delivered for introduction, into commerce, or imported into the United States. Such requirements include the completion of any production changes required under 21 CFR 1004.1 under a plan approved by FDA to assure compliance of future units, and the submission of any required reports. Your response should be sent to: Chief, Electronic Products Branch (HFZ-240), Division of Mammography Quality and Radiation Programs, Office of Communication, Education, and Radiation Programs, Center for Devices and Radiological Health, 1350 Piccard Drive, Rockville, Maryland 20850.
If you have further questions on these requirements, please contact Jerome Dennis of the Electronic Products Branch at (301) 594-3332.
Lynne L. Rice
Office of Communication, Education,
and Radiation Programs
Center for Devices and Radiological Health