510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K091125Substantially Equivalent

Clearwave Phototherapy System for Acne, Model: Cwst2

Verilux, South St. Paul MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K091125 is the FDA 510(k) clearance record for CLEARWAVE PHOTOTHERAPY SYSTEM FOR ACNE, MODEL: CWST2, a class II device, cleared for Verilux on under FDA product code ONE (Powered Light Based Non-Laser Surgical Instrument). FDA's definition for product code ONE reads: "A light based Non-Laser device typically indicated to be used for general surgical purpose in medical specialties of general and plastic surgery, dermatology/aesthetic, podiatry, otolaryngology (ENT), gynecology, neurosurgery, orthopedics...". FDA records list one 510(k) clearance for Verilux. As of , FDA records show no recalls naming K091125.

Clearance record

Decision date
Received
(504 days to decision)
Product code
ONE Powered Light Based Non-Laser Surgical Instrument
Regulation
21 CFR 878.4810
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Verilux 391 Bridge Pt. Dr., South St. Paul MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code ONE

Trailing 12 months

FDA records hold no clearances under product code ONE in the trailing twelve months.

FDA records show no clearances under product code ONE in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code ONE, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260