510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K843915Substantially Equivalent

Mini-Halo CO2 Laser System

CooperVision, Inc., Irvine CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K843915 is the FDA 510(k) clearance record for MINI-HALO CO2 LASER SYSTEM, a class II device, cleared for CooperVision, 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 97 510(k) clearances for CooperVision, Inc., from to . As of , FDA records show no recalls naming K843915.

Clearance record

Decision date
Received
(218 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
CooperVision, Inc. P.O. Box 19587, Irvine CA
Third party review
No

Clearances, product code GEX

Trailing 12 months
70 clearances under product code GEX in the twelve months to October 2026, November 2025 the highest month at 11.
Show the numbers
Monthly 510(k) clearances under FDA product code GEX, trailing twelve months
MonthClearances
November 202511
December 20255
January 20264
February 20266
March 20267
April 20265
May 20268
June 20263
July 20264
August 20264
September 202611
October 20262