510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K854171Substantially Equivalent

I.s.m. Product Family Model P2400c,a & Abc

Intl. Solarium Manufacturer, Inc., North Hollywood CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K854171 is the FDA 510(k) clearance record for I.S.M. PRODUCT FAMILY MODEL P2400C,A & ABC, a class II device, cleared for Intl. Solarium Manufacturer, Inc. on under FDA product code FTC (Light, Ultraviolet, Dermatological). FDA records list 3 510(k) clearances for Intl. Solarium Manufacturer, Inc., from to . As of , FDA records show no recalls naming K854171.

Clearance record

Decision date
Received
(22 days to decision)
Product code
FTC Light, Ultraviolet, Dermatological
Regulation
21 CFR 878.4630
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Intl. Solarium Manufacturer, Inc. 7005 Tujunga Ave., North Hollywood CA
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