# K984110: Laserscope Coolspot

- Pathway: 510(k) (Traditional)
- Applicant: Laserscope
- Decided: Dec 18, 1998 after 31 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.
1,034 later devices descend from it; 4 cite it directly.
0 of 1,035 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) Cool Laser Optics device: named in the summary without a submission number
- (no number) Cold Packs: named in the summary without a submission number

## Most influential descendants
- K020453: Palomar Estelux Pulsed Light System and Palomar Coolroller (2002), 1,018 descendants of its own
- K033946: Lovely System (2004), 737 descendants of its own
- K032460: Profile BBL System (2003), 569 descendants of its own
- K030426: Omnilux Red (2003), 563 descendants of its own
- K042000: Modified MSQ Family of Lovely Light/Laser Systems (2004), 517 descendants of its own

## Indications for use
To provide surface cooling effect during cutaneous laser surgery to minimize thermal injury to non-vascular skin structures during laser therapy of benign cutaneous vascular lesions, and to possibly reduce pain associated with laser treatment.

Source page: https://510kreport.com/device/K984110
Methodology: https://510kreport.com/methodology