510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K091568Substantially Equivalent

Lh-75 Phototherapy System

Lerner Medical Devices, Inc., Los Angeles CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K091568 is the FDA 510(k) clearance record for LH-75 PHOTOTHERAPY SYSTEM, a class II device, cleared for Lerner Medical Devices, Inc. on under FDA product code FTC (Light, Ultraviolet, Dermatological). FDA records list 3 510(k) clearances for Lerner Medical Devices, Inc., from to . As of , FDA records show no recalls naming K091568.

Clearance record

Decision date
Received
(156 days to decision)
Product code
FTC Light, Ultraviolet, Dermatological
Regulation
21 CFR 878.4630
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Lerner Medical Devices, Inc. 1545 Sawtelle Blvd., Suite 36, Los Angeles CA
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