COOLTOUCH— 510(k) K103338

Clearance details

Applicant

New Star Lasers, Inc.

Product code

Code PDZ

Device class

Class 2

Regulation

21 CFR 878.4810

Advisory panel

General, Plastic Surgery

Date received

2010-11-15

Decision date

2011-11-01

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Roseville, CA, US

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• Z-2915-2016 — VariaBreeze; Catalog number: 7300-0035-2. Podiatry: ablation, vaporization, incision, excision, and coagulation of soft tissue including matrixectomy, periungal and subungal warts, plantar warts, radical nail excision, and neuromas. The temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.)Class II·Terminated·New Star Lasers, Inc.·20160919

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K103338.