DeviceClearance

Product code OLP— General, Plastic Surgery

Acne Light Therapy Wand

Classification name
Over-The-Counter Powered Light Based Laser For Acne
Device class
Class 2
Regulation
21 CFR 878.4810
Advisory panel
General, Plastic Surgery
Total cleared
51
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code OLP under 21 CFR 878.4810, via openFDA

Market context for product code OLP

FDA has cleared 51 devices under product code OLP between 2009 and 2026, filed by 43 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code OLP

Adverse events under product code OLP

product code OLP
Other
1
Total
1

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code OLP

Data sourced from openFDA. This site is unofficial and independent of the FDA.