Allengers Global Healthcare Private Limited · Class II · Cleared Dec 17, 2024
| K-number | K242987 |
| Device name | Thulium Fiber Laser (FiberLAZE+, FiberLAZE) |
| Applicant | Allengers Global Healthcare Private Limited |
| Product code | GEX |
| Device class | Class II |
| Decision date | Dec 17, 2024 |
| Decision | Substantially Equivalent |
| Regulation | 878.4810 |
The Thulium Fiber Laser (FiberLAZE+, FiberLAZE) is a laser surgical system that emits light at 1.94 micrometers wavelength with output power up to 60W or 35W, delivered via optical fiber. It is intended for soft tissue incision, excision, resection, ablation, vaporization, coagulation, and hemostasis across urology, lithotripsy, gastroenterology, and gynecological surgery—with specific indications including prostate ablation, stone fragmentation, and various gastrointestinal and gynecological procedures.
The subject device uses a Thulium laser medium at 1.94 micrometers wavelength with pulsed/CW emission, pulse duration 0.1–15ms, pulse frequency 1–2500 Hz, and pulse energy 0.02–6J, delivered via optical fiber with a 532nm aiming beam. The predicate (Fiber Dust, K210142) shares identical wavelength, emission type, pulse duration, and pulse energy but has a lower maximum average power (35W vs. 60W) and lower pulse frequency range (1–1600 Hz vs. 1–2500 Hz). Both devices employ the same delivery and aiming beam systems.
Risk analysis per ISO 14971:2019; electrical and laser safety per IEC 60601-1:2005+A1:2012+A2:2020, IEC 60601-1-2:2014+A1:2020, and IEC 60601-2-22:2019; laser safety per IEC 60825-1:2014; usability per IEC 60601-1-6:2010+A1:2013+A2:2020 and IEC 62366-1:2015/AMD1:2020; and software verification/validation per FDA Content of Premarket Submissions for Device Software Functions (2023).
The subject device is substantially equivalent because it shares the same laser medium, wavelength, emission characteristics, pulse parameters, and delivery mechanism as the predicate device, with identical intended use and design principles. Differences in maximum power (60W vs. 35W) and pulse frequency range (1–2500 Hz vs. 1–1600 Hz) are minor and characterized as 'similar' rather than fundamentally different. Performance testing demonstrates these differences do not introduce new safety or efficacy hazards, and differences in appearance, user interface, and physical dimensions do not affect the core functional equivalence.
View the full FDA submission: accessdata.fda.gov