# K070353: Kelsey Intersitital Laser Therapy System

- Pathway: 510(k) (Traditional)
- Applicant: Kelsey, Inc.
- Decided: May 2, 2007 after 85 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: 8 generations back to K943450 (1995). 26 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012398: Diomed 15 Diode Laser, Diomed, Ltd. (2002) Summary page 1.
- K954195: Indigo Portable Laser System, Inddigo Fiberoptics, Indigo Medical, Inc. (1996) Summary page 1.
- K003953: Indigo Diffuser-Tip Fiberoptic with Temperature Sensing Option, Model LF001, Ethicon Endo-Surgery, Inc. (2001) Summary page 1.
- K003811: Cryocare Surgical System, Endocare, Inc. (2001) Summary page 1.

## Most influential descendants
- K160392: Novilase Laser Therapy System, Model LTS-2 (2016), 0 descendants of its own

## Indications for use
The Kelsey Interstitial Laser Therapy System is indicated for the treatment of fibroadenomas of the breast, with tumor sizes up to 20 mm; and for general surgery procedures including incision, excision and ablation of soft tissues; and coagulative necrosis and interstitial laser coagulation of soft tissue.

Source page: https://510kreport.com/device/K070353
Methodology: https://510kreport.com/methodology