# K013864: Modification to Epi-Star Surgical Laser System, M0DEL DS-60

- Pathway: 510(k) (Traditional)
- Applicant: Nidek, Inc.
- Decided: Feb 8, 2002 after 79 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: 5 generations back to K963094 (1996). 9 ancestors in all.
49 later devices descend from it; 1 cites it directly.
0 of 59 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990119: Epi-Star Surgical Laser Syster, Nidek, Inc. (2000) Summary page 1.

## Most influential descendants
- K040727: CRYO 5 (2004), 48 descendants of its own
- K060407: Juniper Cooling Device (2006), 36 descendants of its own
- K063715: Juniper Cooling Device Xtra (2007), 35 descendants of its own
- K072152: Juniper CLN1 Dermal Cooling Device (2007), 34 descendants of its own
- K080118: Zeltiq Aesthetics CLN1 Dermal Cooling Device (2008), 33 descendants of its own

## Indications for use
The Epi-Star Surgical Laser System is intended to be used for Plastic Surgery and Dermatology, with the intended uses for the treatment of vascular and pigmented lesions and for the removal of hair in skin types I — VL

Source page: https://510kreport.com/device/K013864
Methodology: https://510kreport.com/methodology