# K990119: Epi-Star Surgical Laser Syster

- Pathway: 510(k) (Traditional)
- Applicant: Nidek, Inc.
- Decided: Jul 27, 2000 after 561 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: 4 generations back to K963094 (1996). 8 ancestors in all.
50 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)
- K981447: Dio-Light 60 Laser System, Nidek, Inc. (1998) Summary page 1.
- K973354: Sharplan Epitouch Alexandrite Laser System (5000), Sharplan Lasers, Inc. (1997) Summary page 1.
- K981351: Candela Gentlelase GL Dermatological Laser, Candela Corp. (1998) Summary page 1.
- K971737: Cynosure Photogenica Lpir Dermatological Laser, Cynosure, Inc. (1997) Summary page 1.

## Cited in the summary but kept off the family tree
- K984208: Silverlon Island Dressing, Silverlon Island Pad, Argentum International, LLC (1999). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K013864: Modification to Epi-Star Surgical Laser System, M0DEL DS-60 (2002), 49 descendants of its own
- 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

## 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 in dermatology, and for the removal of hair.

Source page: https://510kreport.com/device/K990119
Methodology: https://510kreport.com/methodology