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
K073066Substantially Equivalent

308 Dermatological Excimer System

Quantel Medical, Hasbrouck Heights NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K073066 is the FDA 510(k) clearance record for 308 DERMATOLOGICAL EXCIMER SYSTEM, a class II device, cleared for Quantel Medical, Inc. on under FDA product code FTC (Light, Ultraviolet, Dermatological). FDA records list 33 510(k) clearances for Quantel Medical, Inc., from to . As of , FDA records show no recalls naming K073066.

Clearance record

Decision date
Received
(57 days to decision)
Product code
FTC Light, Ultraviolet, Dermatological
Regulation
21 CFR 878.4630
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Quantel Medical, Inc. 377 Rte. 17, Hasbrouck Heights NJ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FTC

Trailing 12 months
2 clearances under product code FTC 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 FTC, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20260
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260