# K083927: Waterlase MD

- Pathway: 510(k) (Traditional)
- Applicant: Biolase Technology, Inc.
- Decided: Oct 1, 2009 after 274 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.
26 later devices descend from it; 1 cites it directly.
0 of 27 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) Periolase: named in the summary without a submission number
- (no number) Fidelis III Laser System Family: named in the summary without a submission number
- (no number) Smart C02: named in the summary without a submission number

## Most influential descendants
- K101658: Waterlase MD Turbo Plus Model 7200XXX (2010), 25 descendants of its own
- K161669: Waterlase Express (2016), 21 descendants of its own
- K190319: Waterlase Laser System Family (2019), 19 descendants of its own
- K193656: SkyPulse (2020), 11 descendants of its own
- K193661: LightWalker Laser System Family (2020), 8 descendants of its own

## Indications for use
Waterlase MD Er,Cr:YSGG assisted new attachment procedure (cementum-mediated periodontal ligament new-attachment to the root surface in the absence of long junctional epithelium).

Source page: https://510kreport.com/device/K083927
Methodology: https://510kreport.com/methodology