Over-The-Counter Powered Light Based Laser For Acne

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

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown