Product code OLP
- Device name
- Over-The-Counter Powered Light Based Laser For Acne
- Medical specialty
- General, Plastic Surgery
- Device class
- 2
- Regulation number
- 878.4810
- Review panel
- SU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- 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.
- Source
- FDA openFDA device classification dataset
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| 00622356706926 | Shark CryoGlow | SharkNinja Operating LLC | 2026-06-02 |
| 10622356642801 | Shark CryoGlow | SharkNinja Operating LLC | 2026-06-02 |
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| 16978368600020 | LED Light Therapy Mask | Shenzhen Rainbow Technology Co.,Ltd | 2025-06-05 |
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| 16978368600044 | LED Light Therapy Mask | Shenzhen Rainbow Technology Co.,Ltd | 2025-06-05 |
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