# K980537: ND: Yag Accessory for Photoderm System

- Pathway: 510(k) (Traditional)
- Applicant: Esc Medical Systems, Ltd.
- Decided: Apr 15, 1998 after 63 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
No predicates in its family tree.
1,242 later devices descend from it; 4 cite it directly.
0 of 1,243 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Sharplan 3100 Nd:YAG Laser System: named in the summary without a submission number
- (no number) Laserscope Orion Laser System: named in the summary without a submission number

## Most influential descendants
- K020839: Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DL (2002), 1,046 descendants of its own
- K030527: Lumenis Family of Ipl and Combination Ipl/ND:Yag Systems (2003), 856 descendants of its own
- K030342: Lumenis Family of Ipl Systems and Combination Ipl/ND:Yag Systems (2003), 756 descendants of its own
- K024093: Modified Lumenis Family of Intense Pulsed-Light (Ipl) and Combination Ipl Systems and ND:Yag Laser Systems (2003), 756 descendants of its own
- K991234: The Acme Medical Aesthetic ND:Yag Laser (1999), 755 descendants of its own

## Indications for use
The PhotoDerm® Nd: YAG accessory is intended for coagulation and hemostasis of vascular lesions and soft tissue.

Source page: https://510kreport.com/device/K980537
Methodology: https://510kreport.com/methodology