Inspections, Compliance, Enforcement, and Criminal Investigations
Laser Energetics, Inc. 11/29/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|10903 New Hampshire Ave.|
White Oak #66- 4621
Silver Spring, MD 20993-0002
VIA UNITED PARCEL SERVICE
November 29, 2012
Robert D. Battis
Founder, President & CEO
Laser Energetics, Inc.
3535 Quaker Bridge Road
Mercerville, NJ 08619
Dear Mr. Battis:
This letter is in follow-up to multiple communications from the Food and Drug Administration (FDA) to your firm regarding the Dazer Laser Defender™ model family and Dazer Laser Guardian™ model family. In summary, in April 2010 you communicated by telephone and email with FDA Health Promotion Officer CAPT Dan Hewett, regarding your firm’s intention to respond to an April 6, 2010 letter from FDA that raised questions and concerns regarding your laser product’s compliance with federal regulations. Your firm was requested to provide a reply within 30 working days from the date of the letter.
FDA received an email from you dated April 23, 2010 which requested a meeting with FDA on May 7, 2010 to discuss the questions and concerns in the FDA the letter. Your email suggested that prior to the meeting, FDA should execute an attached Non-disclosure Agreement (NDA). On May 4, 2010 FDA stated by email that the NDA was not necessary because it is FDA policy to treat all discussions with firms it regulates as confidential. FDA requested an agenda prior to the meeting. No agenda was provided, and the meeting did not take place. Your firm did not provide a formal response to the April 6, 2010 letter, and FDA received no reply within the requested 45 days to a follow-up letter sent June 8, 2012.
According to FDA records, Laser Energetics, Inc. (hereafter, “the firm”) is not in compliance with the following FDA regulations:
1. 21 CFR 1002.10 Product Reports. The manufacturer of a product requiring a product report shall submit a product report to CDRH. Specifically, the firm failed to provide a product report to FDA for its Dazer Laser™ and BrightStar™ Alexandrite laser products. Product reports are necessary prior to the introduction of laser products into commerce.
2. 21 CFR 1002.13 Annual Reports. The manufacturer of a product requiring an annual report shall submit an annual report summarizing the contents of records required to maintained by § 1002.30(a). Specifically, FDA has not received any annual reports from the firm.
3. 21 CFR 1003.11 Determination by Secretary that product fails to comply or has a defect. The firm failed to respond to letters dated April 6, 2010 and June 8, 2012 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. Be advised that failure to provide the information called for in the letters is considered a violation of Section 537(b) and 538(a)(2) of the Federal Food, Drug, and Cosmetic Act (the Act), Chapter V, Subchapter C Electronic Product Radiation Control (formerly the Radiation Control for Health and Safety Act of 1968).
4. 21 CFR 1040.11(b) Surveying, leveling and alignment (SLA) laser products. The Dazer Laser products appear to be Class IIIb products which fail to comply with the class limits in § 1040.11(b) applicable to surveying, leveling and alignment laser products. Specifically, all Dazer Laser model families are limited to Class I, IIa, II or IIIa in the visible and Class I in the infrared or equivalent IEC Classes 1, 2, or 3R.
5. 21 CFR 1010.4 Variances. The firm failed to apply for a variance from the performance standard for surveying, leveling and alignment laser products that exceed Class IIIa or International Electrotechnical Commission (IEC) Class 3R. A variance approval is necessary prior to the introduction of Class IIIb or IV, and IEC Class 3B or 4 SLA laser products into commerce.
Once the use of a product is determined to be a SLA product within the meaning of 21 CFR 1040.10(39), the product is subject to laser class limitations in 21 CFR 1040.11(b). The requirements for SLA products are "designed to transmit laser radiation through open space for measuring and positioning purposes" (38 Federal Register, FR 34084, at 34085; December 10, 1973). The requirements are intended to "impose appropriate upper limits on the accessible laser emission from such products consistent with their intended function and the generally unrestricted environments in which they are used".
The uses of the Dazer Laser™ products are consistent with the uses of products that FDA has considered to be SLA products. Such laser products include products described as target pointer illuminator aiming, tactical laser illuminator, infrared zoom illuminator, and laser illuminator. Illuminator, alignment, target designation, pointing, or any similar description of a laser product for use in alignment or positioning provides a basis for classification of a laser product as a surveying, leveling, or alignment laser product. The divergence of the beam is not a factor in this classification because straight line alignment is not dependent upon the width of the beam or the distance between the source and termination of the beam.
For the reasons stated above, one or more of your laser products may not be compliant with the Class I infrared and/or Class IIIa visible class limits in 1040.11(b). CDRH intends that where the CFR specifies that laser products must conform to 1040.11(b), International Electrotechnical Commission (IEC) laser classes 1, 2, and 3R do not exceed these class limits for visible and invisible laser emissions. Please note the IEC laser classes 1M, 2M, 3B and 4 do not conform to 1040.11(b).
Your firm should work through the performance standard under 1040.10 and .11 to find the previously stated class limit and product reporting regulations, note any non-compliances, correct them, and submit product reports under 21 CFR 1002.10.
After you re-assess your product(s) your firm is obligated under 21 CFR 1003.10 to notify FDA of all defects or non-compliances in the manner described in 1003.20. Since non-compliances potentially affect units that have entered into commerce, your firm may have obligations under Part 1004 to repurchase, repair or replace your laser products that have been sold to purchasers, dealers or distributors.
If any products exceed SLA product Class limits, a variance application approval is necessary before unsold products may enter into commerce.
Your internet website states that your products have military applications. It is the CDRH’s position that CDRH will not grant variances for products that allow the products to also be sold to the Department of Defense (DoD), based on a November 8, 2002 memorandum from the DoD Laser System Safety Working Group (LSSWG). Firms that sell laser products that do not comply with the performance standard, and are sold to the DoD, must seek prior authorization from a DoD contracting officer under FDA exemption no. 76EL-01DOD, which was granted in 1976 to allow DoD to procure laser products for reasons of combat, combat training or for classified reasons of national security. We request that you provide such a response no later than 15 days after receipt of this letter with the number of laser products which have been produced, the number of such products that have left the place of manufacture, and the current location of such products.
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. § 360oo(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.
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 non-compliances 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, Magnetic Resonance and Electronic Products Branch
Division of Radiological Health
Office of In Vitro Diagnostics and Radiological Health
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.
Alberto Gutierrez, Ph.D.
Office of In Vitro Diagnostics
and Radiological Health
Center for Devices and Radiological Health