# Over-The-Counter Powered Light Based Laser For Acne
> **Product code: OLP** · Class II — Moderate Risk (510(k) clearance required) · General, Plastic Surgery · 21 CFR 878.4810
## Classification
- **FDA Product Code:** OLP
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 878.4810
- **Review panel:** SU
- **Medical specialty:** General, Plastic Surgery
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## 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.

## Market data
- **Cleared 510(k) submissions:** 51
- **Registered establishments:** 103
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=OLP)
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