# K071734: Waterlase MD Derm

- Pathway: 510(k) (Traditional)
- Applicant: Biolase Technology, Inc.
- Decided: Jan 25, 2008 after 213 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 later device descends from it; 1 cites it directly.
0 of 2 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) Millenium 7: named in the summary without a submission number
- (no number) DermaLase: named in the summary without a submission number
- (no number) MCL 30 Dermablate: named in the summary without a submission number

## Most influential descendants
- 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/K071734
Methodology: https://510kreport.com/methodology