Manufacturer
Realton (Suzhou) Medical Technology Co., Ltd.FLARE Single-Use Surgical Laser Fiber
Realton (Suzhou) Medical Technology Co., Ltd.
Country / Region:China (CN)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Device details
FDA 510(k) registration fields
- K number
- K202702
- Device name
- FLARE Single-Use Surgical Laser Fiber
- Country / Region
- China(CN)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2020-09-16
- Decision date
- 2021-02-26
- Submission type
- Traditional
- Technology type
- Laser fiber / delivery(AI inferred)
- Clinical applications
- Surgical cuttingOther
- Primary application
- Surgical cutting
- Classification source
- AI classified
Indications for Use
FLARETM single-use surgical laser fiber is intended to be used to deliver the laser radiation to the target tissue when used with compatible surgical lasers with operational wavelength between 532 nm- 2140 nm and equipped with SMA 905 compatible connector. FLARETM single-use surgical laser fiber is indicated for use in general surgical applications for open, laparoscopic, and endoscopic ablation, vaporization, excision, incision, coagulation of soft tissue and for lithotripsy.
Intended Use
FLARETM single-use surgical laser fiber is intended to be used to deliver the laser radiation to the target tissue when used with compatible surgical lasers with operational wavelength between 532 nm- 2140 nm and equipped with SMA 905 compatible connector. FLARETM single-use surgical laser fiber is indicated for use in general surgical applications for open, laparoscopic, and endoscopic ablation, vaporization, excision, incision, coagulation of soft tissue and for lithotripsy.
Device Description
FLARETM single-use surgical laser fiber is designed, manufactured by Realton (Suzhou) Medical Technology Co., Ltd. The optical fiber material is fused quartz. One end of the fiber is connected to the medical laser equipment through a connector, and the other end directly outputs laser energy for laser operation. The product is sterilized by EO. It is a disposable medical device.
Summary parsed at:2026-06-01 05:41:45 UTC
Predicate devices
1Lumenis Family of Holmium Surgical Lasers and Delivery Devices and Accessories
K202702 references 1 predicate/reference device
Cited as predicate
1LGO-Surgical Laser Fibers
1 submission cite K202702 as a predicate
