# K052354: Oculase MD

- Pathway: 510(k) (Traditional)
- Applicant: Biolase Technology, Inc.
- Decided: Jul 5, 2006 after 310 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: 9 generations back to K910422 (1992). 178 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 184 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031140: Waterlase, Biolase Technology, Inc. (2004) Summary page 1.
- K030523: Waterlase, Biolase Technology, Inc. (2004) Summary page 1.
- K012511: Waterlase Millennium, Biolase Technology, Inc. (2002) Summary page 1.
- K011041: Waterlase, Millennium, Biolase Technology, Inc. (2001)
- K971459: Dermalase, Endo Technic Corp. (1997) Summary page 1.
- K042000: Modified MSQ Family of Lovely Light/Laser Systems, Msq (M2), Ltd. (2004) Summary page 1.
- K971843: Laserscope Vela Erbium:Yag Laser System and Accessories, Laserscope (1997) Summary page 1.
- K964128: MCL 29 Dermablate Erbium Laser System, Aesculap-Meditec GmbH (1997) Summary page 1.
- K905141: Centauri, Pfizer Laser Systems (1991) Summary page 1.
- K000023: Friendly Light ER:Yag Pulsed Laser, Innotech USA, Inc. (2000) Summary page 1.

## Most influential descendants
- 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
- K070296: Visiolite Ophthalmic ER: Yag Laser System (2007), 0 descendants of its own

## Indications for use
The Oculase MD may be indicated for general ophthalmic soft tissue surgical indications such as: Incision, excision, vaporization and coagulation of ocular tissue and tissue surrounding the eye and orbit.

Source page: https://510kreport.com/device/K052354
Methodology: https://510kreport.com/methodology