# K073496: Optilite Holmium Laser Fibers

- Pathway: 510(k) (Traditional)
- Applicant: Cook Urological, Inc.
- Decided: Jan 23, 2008 after 42 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K992866 (1999). 2 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K994010: Innovaquartz General Shape Laser Fiber, Innovaquartz (1999) Summary page 1.
- K992866: Optilite IX Laser Surgery Accessories, Convergent Laser Technologies (1999) Summary page 1.

## Most influential descendants
- K124030: Cook Holmium Laser Fiber (2013), 2 descendants of its own
- K163197: Cook Holmium Laser Fiber (2017), 0 descendants of its own
- K133788: Cook Holmium Laser Fiber (2015), 0 descendants of its own
- K090281: Accutech Family of Powerflex Laser Delivery Devices (2009), 0 descendants of its own

## Recalls of this device
- May 3, 2017 · Class II · Z-2585-2017: Cook Inc. is initiating a voluntary recall of the OptiLite Multi-Use Holmium Laser Fibers because it has been identified that the reprocessing instructions do not provide sufficiently detailed informa

## Indications for use
Indicated for incision/excision, ablation, and coagulation (homeostasis) when attached to cleared laser systems such as KTP, Nd:YAG, Argon, Diode, Ho:YAG and ER:YAG wavelengths for the indications for which the lasers have been cleared.

Source page: https://510kreport.com/device/K073496
Methodology: https://510kreport.com/methodology