510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K262426Substantially Equivalent

Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)

Wuhan Pioon Technology Co., Ltd., Wuhan, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

Clearance record

Decision date
Received
(56 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 Pioon Technology Co., Ltd. 12th Floor, Bldg. 1, Innovative Unit, R&D Center Project, Ma, 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