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Medical Diode Laser (M2)

Wuhan Pioon Technology Co., Ltd.

Country / region:China (CN)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Company

Wuhan Pioon Technology Co., Ltd.
China (CN)

Product code

GEX
21 CFR 878.4810

Predicate devices

1
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Cited as predicate

1
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Device details

FDA 510(k) registration fields

K number
K230274
Device name
Medical Diode Laser (M2)
Company
Wuhan Pioon Technology Co., Ltd.
Country / region
China(CN)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2023-02-01
Decision date
2023-03-31
Submission type
Traditional
Technology type
Diode(AI inferred)
Clinical applications
Surgical cutting
Primary application
Surgical cutting
Classification source
AI classified

Indications for Use

Medical Diode Laser is intended to incision, excision, ablation, vaporization, hemostasis and/or coagulation of soft tissue.

Intended Use

Medical Diode Laser is intended to incision, excision, ablation, vaporization, hemostasis and/or coagulation of soft tissue.

Device Description

The predicated device is Fotona SkyPulse Laser Platform (K193656), a 1940nm Diode Laser with same intended use as the subject device. Energy source: Solid state diode. Configuration: Main Unit, Foot Control. Laser Wavelength: 1940nm. Laser Classification: Class IV. Power range: Up to 7.5W. Pulse width: CW or 10 ms – 10 s. Repetition rate: CW or up to 100 Hz. Delivery system: Fiber delivery. User interface: Touch screen control. Safety feature: Complied with IEC 60601-1:2005+AMD1:2012+AMD2:2020, IEC 60601-1-2:2014+A1:2020, IEC 60601-2-22:2019, IEC 60825-1:2014.

Summary parsed at:2026-06-01 05:32:30 UTC

Predicate devices

1

K230274 references 1 predicate/reference device

Cited as predicate

1

1 submission cite K230274 as a predicate