510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K103338Substantially Equivalent

Cooltouch

New Star Lasers, Inc., Roseville CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K103338 is the FDA 510(k) clearance record for COOLTOUCH, a class II device, cleared for New Star Lasers, Inc. on under FDA product code PDZ (Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis). FDA's definition for product code PDZ reads: "For the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T mentagrophytes, and/or yeasts Candida albicans, etc.)". FDA records list 29 510(k) clearances for New Star Lasers, Inc., from to . As of , FDA records show one recall naming K103338.

Clearance record

Decision date
Received
(351 days to decision)
Product code
PDZ Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis
Regulation
21 CFR 878.4810
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
New Star Lasers, Inc. 9085 Foothills Blvd., Roseville CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PDZ

Trailing 12 months
1 clearance under product code PDZ 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 PDZ, 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