510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
Medical Device
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K943201Substantially Equivalent

Clean Air

CooperSurgical, Inc., Milford CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K943201 is the FDA 510(k) clearance record for CLEAN AIR, a class II device, cleared for Wallach Surgical Devices, Inc. on under FDA product code GEX (Powered Laser Surgical Instrument). FDA's definition for product code GEX reads: "A laser (light amplification by stimulated emission of radiation) based device having coherence, collimated and typically monochromatic radiation. Typically indicated to to cut, destroy, remove or coagulate tissue, generally soft tissue...". FDA records list 103 510(k) clearances for COOPERSURGICAL, INC., from to . As of , FDA records show no recalls naming K943201.

Clearance record

Decision date
Received
(238 days to decision)
Product code
GEX Powered Laser Surgical Instrument
Regulation
21 CFR 878.4810
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Wallach Surgical Devices, Inc. 291 Pepe'S Farm Rd., Milford CT
510(k) summary
Statement
Third party review
No

Clearances, product code GEX

Trailing 12 months
62 clearances under product code GEX in the twelve months to November 2026, September 2026 the highest month at 11.
Show the numbers
Monthly 510(k) clearances under FDA product code GEX, trailing twelve months
MonthClearances
December 20255
January 20264
February 20266
March 20267
April 20265
May 20268
June 20263
July 20264
August 20264
September 202611
October 20265
November 20260