FDA WARNING_LETTER - Laserworld USA Inc.

The FDA issued a Warning Letter to Laserworld USA regarding noncompliance of their high-power laser light show projectors, models CS-1000RGB and CS-2000RGB, with the Federal Food, Drug, and Cosmetic Act, Subchapter C, Electronic Product Radiation Control, Section 538(a). This was discovered during an FDA evaluation of products purchased by the U.S. government.

Violations of 21 CFR 1010.4, 1040.10, and 1040.11(c) include: 1. **Failure to provide safety interlocks (21 CFR 1040.10(f)(2)(i))**: Despite a product report stating housing removal requires "special tools" and is factory-only, the user manual instructs customers to open the device for maintenance, exposing them to Class IV laser emissions without interlocks. FDA confirmed the housing could be opened with a regular Phillips screwdriver. 2. **Failure to provide a remote interlock connector (21 CFR 1040.10(f)(3))**: Laser emissions exceeding Class I limits were visible outside the protective housing after terminal connections were opened and the power switch was turned off. 3. **Failure to provide a key-actuated master control (21 CFR 1040.10(f)(4))**: Visible