Laser Fiber (PT-OF-A-S); Laser Fiber (PT-OF-B-S); Laser Fiber (PT-OF-C-S); Laser Fiber (PT-OF-D-S); Laser Fiber (PT-OF-E-S); Laser Fiber (PT-OF-F-S)
Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.
Country / Region:China (CN)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K253007
- Device name
- Laser Fiber (PT-OF-A-S); Laser Fiber (PT-OF-B-S); Laser Fiber (PT-OF-C-S); Laser Fiber (PT-OF-D-S); Laser Fiber (PT-OF-E-S); Laser Fiber (PT-OF-F-S)
- Country / Region
- China(CN)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2025-09-19
- Decision date
- 2025-11-20
- 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
PT-OF-X-S Series Laser Fiber (Models PT-OF-A-S, PT-OF-B-S, PT-OF-C-S, PT-OF-D-S, PT-OF-E-S, PT-OF-F-S) is indicated for to deliver laser energy from a source to the target tissue in laser surgery applications, when used with any cleared/certified laser with wavelengths 1940nm - 2100nm equipped with SMA 905 standard connector.
Intended Use
PT-OF-X-S Series Laser Fiber (Models PT-OF-A-S, PT-OF-B-S, PT-OF-C-S, PT-OF-D-S, PT-OF-E-S, PT-OF-F-S) is indicated for to deliver laser energy from a source to the target tissue in laser surgery applications, when used with any cleared/certified laser with wavelengths 1940nm - 2100nm equipped with SMA 905 standard connector.
Device Description
The PT-OF-X-S Series Laser Fiber is a reusable (up to 10 uses) optical fiber delivery system designed to transmit laser energy from compatible laser sources to surgical treatment sites. The device utilizes high-purity quartz glass core technology with total internal reflection principles to deliver precise laser energy for various surgical applications. The system features an SMA-905 standard connector for universal compatibility with cleared laser systems operating at wavelengths between 1940nm and 2100nm. Each fiber incorporates an integrated RFID module for usage tracking and cycle management, ensuring safe reuse within validated parameters. The device is supplied non-sterile and requires.
Summary parsed at:2026-06-01 05:24:27 UTC
Predicate devices
1LGO-Surgical Laser Fibers
K253007 references 1 predicate/reference device
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K253007 as a predicate
