Laser Energetics, Inc. – FDA Warning Letter

This FDA Warning Letter, dated November 29, 2012, addresses Laser Energetics, Inc. regarding non-compliance of its Dazer Laser Defender™ and Dazer Laser Guardian™ model families, and BrightStar™ Alexandrite laser products. The letter follows multiple communications and the firm's failure to respond to previous FDA inquiries from April 2010 and June 2012.

Key violations include: 1. **Failure to submit Product Reports (21 CFR 1002.10)** for Dazer Laser™ and BrightStar™ Alexandrite products, required before introduction into commerce. 2. **Failure to submit Annual Reports (21 CFR 1002.13)**. 3. **Failure to respond to FDA letters (21 CFR 1003.11)** requesting information on product production and distribution, a violation of Section 537(b) and 538(a)(2) of the Federal Food, Drug, and Cosmetic Act. 4. **Non-compliance with Surveying, Leveling, and Alignment (SLA) laser product standards (21 CFR 1040.11(b))**: Dazer Laser products appear to be Class IIIb, exceeding the Class I, IIa, II, or IIIa limits for visible light and Class I for infrared, or equivalent IEC Classes