# K971743: Sharplan CO2 Surgical Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Sharplan Lasers, Inc.
- Decided: Jul 18, 1997 after 67 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: 1 generation back to K950725 (1995). 2 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K950725: Sharplan Model 1015 CO2 Laser, Sharplan Lasers, Inc. (1995) Summary page 1.
- K954460: Ilt Surgical Laser, Ion Laser Technology (1995) Summary page 1.

## Most influential descendants
- K132661: Lightscalpel (2014), 3 descendants of its own
- K141658: Light Scalpel (2014), 2 descendants of its own
- K213669: Lightscalpel LS-4020 (2023), 0 descendants of its own
- K173827: LightScalpel (2018), 0 descendants of its own

## Indications for use
The Sharplan 15F CO2 Laser System is intended for use as a heat source to activate tooth bleaching materials.

Source page: https://510kreport.com/device/K971743
Methodology: https://510kreport.com/methodology