# FDA WARNING_LETTER - Laser Energetics, Inc. - Unknown Date

Source: https://www.globalkeysolutions.net/records/warning_letter/laser-energetics-inc/b1217db5-c897-42cf-83c8-faea10aa8723

> FDA WARNING_LETTER for Laser Energetics, Inc. on Unknown Date. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Laser Energetics, Inc.
- Product Type: Devices
- Office Name: Department of Health and Human Services
- Summary: 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

## Related Officers

- [Director](https://www.globalkeysolutions.net/people/alberto-gutierrez/ec16aa77-9dd3-4aff-aae4-1540ea96c5b8)

Company: https://www.globalkeysolutions.net/companies/laser-energetics-inc/b5175ed5-c878-4334-878c-3fa06cfc6afb

Office: https://www.globalkeysolutions.net/offices/department-of-health-and-human-services/cecfcda4-4afa-4a1f-a7b7-a020b79f9861