510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K160549Substantially Equivalent

Medical Diode Laser Systems

Wuhan Gigaa Optronics Technology Co., Ltd., East Lake Development Zone, Wuhan, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K160549 is the FDA 510(k) clearance record for MEDICAL DIODE LASER SYSTEMS, a class II device, cleared for Wuhan Gigaa Optronics Technology Co., Ltd. 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 2 510(k) clearances for Wuhan Gigaa Optronics Technology Co., Ltd., from to . As of , FDA records show no recalls naming K160549.

Clearance record

Decision date
Received
(403 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
Wuhan Gigaa Optronics Technology Co., Ltd. 5, 6/F, Unit A, B, Bldg. B8, Hi-Tech Medical Device, East Lake Development Zone, Wuhan, CN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GEX

Trailing 12 months
68 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 20260