# K973172: Resposable Bare Fibers

- Pathway: 510(k) (Traditional)
- Applicant: Trimedyne, Inc.
- Decided: Feb 3, 1998 after 162 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
No predicates in its family tree.
248 later devices descend from it; 4 cite it directly.
0 of 249 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Trimedyne Disposable Holmium Bare Fibers: named in the summary without a submission number

## Most influential descendants
- K050738: FT Fiber Optic Delivery Systems (2005), 225 descendants of its own
- K060033: Profile Multi-Platform System (2006), 221 descendants of its own
- K073063: 15W Ceralas D 1470NM Diode Laser (2008), 202 descendants of its own
- K083613: Quanta System Polysurge Diode Laser Family (2008), 192 descendants of its own
- K090164: Ceralas Multiwavelength 980/1470NM Diode Laser (2009), 177 descendants of its own

## Indications for use
Incision, excision, resection, ablation, vaporization, coagulation and hemostasis.

Source page: https://510kreport.com/device/K973172
Methodology: https://510kreport.com/methodology