# K052604: Starlite 2006

- Pathway: 510(k) (Traditional)
- Applicant: Laser Dental Innovations
- Decided: Dec 16, 2005 after 86 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 summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K091994: Mountaineer Laminoplasty System, Depuy Spine, Inc. (2010). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K082445: CURATIVE980 Diode Laser (2008), 0 descendants of its own

## Indications for use
The Starlite 2006 will be used with the following lasers for the excision, ablation., vaporization and hemostasis of soft tissue. Diolase ST produced by American Dental Technologies (810 Nm operating wavelength) Twilight produced by Biolase (810 Nm operating wavelength) Diodent produced by Hoya Con Bio (810 Nm operating wavelength) Softlase produced by Zap Lasers (810 Nm operating wavelength) Aurora produced by Premier Lasers (810 Nm operating wavelength) indications of use summary statement: The StarLite laser fiber optic can be used for all the of the lasers cited above as well as other diode soft tissue lasers operating using the same wavelengths. The StarLite will become an integral part of the laser system and by default be cleared for the same indications and procedures as the laser it is deployed on

Source page: https://510kreport.com/device/K052604
Methodology: https://510kreport.com/methodology