General & Plastic Surgery Medical Laser Products
Definition: The Device Is Intended For Over-the-counter (otc) Use To Treat Patients With Mild To Moderate Acne Vulgaris. The Device Is Intended To Emit Energy In The Red And Blue Region Of The Spectrum, Specifically Indicated To Treat Mild To Moderate Acne Vulgaris.
Applicable Standards: Laser Products. [1040.10] Specific Purpose Laser Products. [1040.11]
| Radiation Type | Optical |
| Radition Safety | Product |
| Annual Reports | Yes |
| 5812 | Over-the-counter Powered Light Based Laser For Acne | Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology. |
| 5812 | Over-the-counter Powered Light Based Laser For Acne | Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology. |
| Over-The-Counter Powered Light Based Laser For Acne [30278] | 21 CFR §878.4810 🔎 |
| Over-The-Counter Powered Light Based Laser For Acne [38651] | 21 CFR §878.4810 🔎 |
| Over-The-Counter Powered Light Based Laser For Acne [38649] | 21 CFR §878.4810 🔎 |
| Over-The-Counter Powered Light Based Laser For Acne [38650] | 21 CFR §878.4810 🔎 |
| Over-The-Counter Powered Light Based Laser For Acne [34006] | 21 CFR §878.4810 🔎 |
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