# K960413: Coherent Slimline Single Lumen Aspiration Needle Kit

- Pathway: 510(k) (Traditional)
- Applicant: Lumenis, Inc.
- Decided: Apr 4, 1996 after 66 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 K902990 (1990). 3 ancestors in all.
483 later devices descend from it; 4 cite it directly.
0 of 487 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K923575: Coherent Versapluse 2.1 Holmium Surg. Lasers, Coherent Medical Group (1993) Summary page 1.
- K902990: Coherent Holmium:Yag Surgical Laser, Coherent Medical Division (1990) Summary page 1.
- K913136: Laser Endoscope Disc Decompression Kits, Medical Laser, Inc. (1991) Summary page 1.

## Most influential descendants
- K980685: Modified Versapulse Select HO:Yag and HO:Yag/ND:Yag Lasers (1998), 351 descendants of its own
- K990947: Modified Versapulse Select Single Wavelength, HO: Yag and Dual Wavelength, HO: Yag/ND: Yag Surgical Lasers and  Delivery (1999), 350 descendants of its own
- K011703: Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength (HO:Yag/ND:Yag) Surgical Lasers and Delivery Devices (2001), 342 descendants of its own
- K050738: FT Fiber Optic Delivery Systems (2005), 225 descendants of its own
- K060033: Profile Multi-Platform System (2006), 221 descendants of its own

## Indications for use
The Coherent SlimLine Single Lumen Aspiration Needle Set and the Delivery Accessories that are used with them to deliver light energy are indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: dermatology; plastic surgery; podiatry; neurosurgery; gynecology; otorhinolaryngology (ENT); arthroscopy (knee surgery); and open and endoscopic general surgery, and for aspiration and/ or irrigation of fluid and/or surgical debris.

Source page: https://510kreport.com/device/K960413
Methodology: https://510kreport.com/methodology