# K021848: Clarus Straight Firing Laser Fiber; Clarus Side Firing Laser Fiber; Models 1150, 1160

- Pathway: 510(k) (Traditional)
- Applicant: Clarus Medical, LLC
- Decided: Sep 3, 2002 after 90 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: 1 generation back to K922881 (1992). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K922881: Clarus Models 1100, 1101, 1102, 1103 Laser Disc, Clarus Medical Systems, Inc. (1992) Summary page 1.
- K011207: Laser Peripherals Reusable Holmium Fiber, Laser Peripherals, LLC (2001)
- K973172: Resposable Bare Fibers, Trimedyne, Inc. (1998) Summary page 1.
- K992083: Scatterfree Lateral Emitting Fiber, Laser Peripherals, LLC (1999) Summary page 1.
- K972272: Laser Peripherals Holmium Bare Fibers, Laser Peripherals, LLC (1997) Summary page 1.

## Indications for use
The Clarus Straight Firing Laser Fiber and the Clarus Side Firing Lasers Fiber are for use in general, urological, OB-GYN, orthopedic, and ENT laser surgical procedures for cutting, vaporizing, or coagulating in any soft tissue application for which Ho:YAG lasers have been cleared.

Source page: https://510kreport.com/device/K021848
Methodology: https://510kreport.com/methodology