# K170366: Laser Peripherals, LLC Family of Bare Laser Fibers

- Pathway: 510(k) (Traditional)
- Applicant: Laser Peripherals, LLC
- Decided: Jun 8, 2017 after 122 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 22 generations back to K943450 (1995). 401 ancestors in all.
13 later devices descend from it; 6 cite it directly.
0 of 415 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K124003: Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and Aspirating Laser Probes, Med-Fibe, Med-Fibers, Inc. (2013) Summary page 8.
- K142638: ProFlex Laser Fibers (ProFlex 200) and ProFlex Laser Fibers (PRoFlex 273), Innovaquartz, LLC (2014) Summary page 8.

## Most influential descendants
- K220189: LISA Laser Surgical Fibers (2022), 5 descendants of its own
- K241643: WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R) (2025), 2 descendants of its own
- K200234: Surgical laser fibers (2020), 2 descendants of its own
- K252745: Halo Sterile Single-use Radial Fiber (Halo-R-0.40-2.5/Halo-R-0.60-2.5/Novo-R-0.60-1.8/Novo-R-0.40-1.8) (2025), 1 descendant of its own
- K243147: LGO-Surgical Laser Fibers (2024), 1 descendant of its own

## Indications for use
The Laser Peripherals Laser Fiber is indicated for use in all surgical specialties in which compatible laser systems with operational wavelengths between 500nm — 2200nm have received regulatory clearance. Laser Peripherals surgical fiber optic laser delivery devices are intended for use with any cleared surgical laser with an SMA 905 connector, SMA 906 connector, or manufacturer specific connectors and adaptors.

Source page: https://510kreport.com/device/K170366
Methodology: https://510kreport.com/methodology