510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K936048Substantially Equivalent

Lightwear(tm) Syst (Lightwear Headlight Clip/headband)

Cogent Light Technologies, Inc., Valencia CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K936048 is the FDA 510(k) clearance record for LIGHTWEAR(TM) SYST (LIGHTWEAR HEADLIGHT CLIP/HEADBAND), a class II device, cleared for Cogent Light Technologies, Inc. on under FDA product code FST (Light, Surgical, Fiberoptic). FDA records list 5 510(k) clearances for Cogent Light Technologies, Inc., from to . As of , FDA records show no recalls naming K936048.

Clearance record

Decision date
Received
(80 days to decision)
Product code
FST Light, Surgical, Fiberoptic
Regulation
21 CFR 878.4580
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Cogent Light Technologies, Inc. 26145 Technology Dr., Valencia CA
510(k) summary
Statement
Third party review
No

Clearances, product code FST

Trailing 12 months

FDA records hold no clearances under product code FST in the trailing twelve months.

FDA records show no clearances under product code FST in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FST, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260