# K971648: Sharplan Erbium: Yag Laser (4020)

- Pathway: 510(k) (Traditional)
- Applicant: Sharplan Lasers, Inc.
- Decided: Jul 23, 1997 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: 3 generations back to K954013 (1996). 5 ancestors in all.
58 later devices descend from it; 2 cite it directly.
0 of 64 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954013: Trilase 2940 Erbium Laser, Schwartz Electro-Optics, Inc. (1996) Summary page 1.
- K962902: Fotona Skinlight Laser System, Medical Laser Solutions (1997) Summary page 1.
- K961748: Medlite/Erbium Laser System, Continuum Biomedical, Inc. (1996) Summary page 1.
- K964128: MCL 29 Dermablate Erbium Laser System, Aesculap-Meditec GmbH (1997) Summary page 1.
- (no number) ESC Derma 20 Erbium:YAG Laser: named in the summary without a submission number

## Most influential descendants
- K981438: Dornier Medilas E (1998), 56 descendants of its own
- K050317: Burane XL (2005), 53 descendants of its own
- K052806: Burane (2005), 52 descendants of its own
- K082947: Lensx 550 Laser System (2009), 51 descendants of its own
- K094052: Lensx 550 Laser System. Model 550 (2010), 47 descendants of its own

## Indications for use
The Sharplan Model 4020 Erbium:YAG Surgical Laser System is intended for incision/excision, ablation, vaporization, and/or coagulation of soft tissue in Plastic Surgery/Dermatology.

Source page: https://510kreport.com/device/K971648
Methodology: https://510kreport.com/methodology