# K971459: Dermalase

- Pathway: 510(k) (Traditional)
- Applicant: Endo Technic Corp.
- Decided: Jul 18, 1997 after 88 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). 4 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961748: Medlite/Erbium Laser System, Continuum Biomedical, Inc. (1996) Summary page 1.
- K954013: Trilase 2940 Erbium Laser, Schwartz Electro-Optics, Inc. (1996) Summary page 1.
- K964128: MCL 29 Dermablate Erbium Laser System, Aesculap-Meditec GmbH (1997) Summary page 1.
- K952118: ELMER, Biological Technology Corp. (1995) Summary page 1.

## Most influential descendants
- K052354: Oculase MD (2006), 5 descendants of its own
- K063867: Cutera ER:Ysgg Laser Handpiece (2007), 2 descendants of its own
- K080530: Modification to Cutera ER:Ysgg Laser Handpiece (2008), 1 descendant of its own
- K210183: Waterlase iPLus (2022), 0 descendants of its own
- K141975: Waterlase Iplus S (2015), 0 descendants of its own

## Indications for use
Use of the device is indicated for the incision, excision, ablation, vaporization and coagulation of dermatologic tissues including epidermal nevi, cheilitis, keloids, verrucae, skin tags, keratosis, scar revision, debulking of tumors, cysts, diagnostic biopsy and skin resurfacing. Use of the device is further indicated for the incision, excision, vaporization and coagulation of soft tissue during general surgical applications where skin incision, tissue disection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors and lesions, tissue ablation and/or vessel coagulation may be indicated

Source page: https://510kreport.com/device/K971459
Methodology: https://510kreport.com/methodology