510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K162450Substantially Equivalent

ESPADA Acne-Clearing Blue Light Pen

Foreo Inc, Las Vegas NV / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K162450 is the FDA 510(k) clearance record for ESPADA Acne-Clearing Blue Light Pen, a class II device, cleared for Foreo, Inc. on under FDA product code OLP (Over-The-Counter Powered Light Based Laser For Acne). FDA's definition for product code OLP reads: "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...". FDA records list 10 510(k) clearances for Foreo, Inc., from to . As of , FDA records show no recalls naming K162450.

Clearance record

Decision date
Received
(90 days to decision)
Product code
OLP Over-The-Counter Powered Light Based Laser For Acne
Regulation
21 CFR 878.4810
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Foreo, Inc. 1525 Pama Ln., Suite 200, Las Vegas NV
510(k) summary
Statement
Third party review
No

Clearances, product code OLP

Trailing 12 months
1 clearance under product code OLP in the twelve months to October 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code OLP, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260