PHOTOTHERAPEUTIX MODEL 1650B— 510(k) K933953

Name: FDA 510(k) clearance K933953
Creator: U.S. Food and Drug Administration
Published: 1995-02-21

Substantially Equivalent

Avex Industries , Ltd.

FDA 510(k) clearance K933953 for PHOTOTHERAPEUTIX MODEL 1650B, Substantially Equivalent on 1995-02-21. Applicant: Avex Industries , Ltd.. Device class: 2.

Clearance details

Applicant: Avex Industries , Ltd.
Product code: Code FTC
Device class: Class 2
Regulation: 21 CFR 878.4630
Advisory panel: General, Plastic Surgery
Date received: 1993-08-12
Decision date: 1995-02-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hudson Falls, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FTC

view all

K254234 — Phototherapy System (DUV-COMBO)2026-05-01
K253871 — Klär Lite (RCW-KL1000)2026-03-04
K250425 — Ultraviolet Phototherapy Device2025-04-07
K244022 — 308nm UV Phototherapy System (4 models)2025-03-13
K242977 — 308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K)2025-02-06

More clearances from Avex Industries , Ltd.

view all

K935525 — PHOTOTHERAPEUTIX MODEL 2480AB1995-05-19
K933952 — PHOTOTHERAPEUTIX MODEL 800B1995-02-21
K933954 — PHOTOTHERAPEUTIX MODEL 2400B1995-02-21
K935524 — PHOTOTHERAPEUTIX MODEL 3200A1995-02-17
K935526 — PHOTOTHERAPEUTIX MODEL 1600B1995-02-17

Data sourced from openFDA. This site is unofficial and independent of the FDA.