510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K860975Substantially Equivalent

Model 545-45 Laser for Ear, Nose & Throat

Britt Corp., Inc., Los Angeles CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K860975 is the FDA 510(k) clearance record for MODEL 545-45 LASER FOR EAR, NOSE & THROAT, a class II device, cleared for Britt Corp., Inc. on under FDA product code EWG (Laser, Ent Microsurgical Carbon-Dioxide). FDA records list 3 510(k) clearances for Britt Corp., Inc., from to . As of , FDA records show no recalls naming K860975.

Clearance record

Decision date
Received
(126 days to decision)
Product code
EWG Laser, Ent Microsurgical Carbon-Dioxide
Regulation
21 CFR 874.4500
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Britt Corp., Inc. 2231 S. Barrington Ave., Los Angeles CA
Third party review
No

Clearances, product code EWG

Trailing 12 months

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

FDA records show no clearances under product code EWG in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code EWG, 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