# K983654: Cyber-Lase 2000 Curing and Whitening Laser

- Pathway: 510(k) (Traditional)
- Applicant: Ics of North America, Inc.
- Decided: Jan 12, 1999 after 85 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: 1 generation back to K961682 (1996). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971118: ARAGO, Premier Laser Systems, Inc. (1997) Summary page 1.
- K961682: Argon Curing Laser, Premier Laser Systems, Inc. (1996) Summary page 1.
- K970637: Accucure 1000, Lasermed, Inc. (1997) Summary page 1.
- (no number) American Medical laser: named in the summary without a submission number

## Indications for use
This device is intended for use in: 1. Source of illumination for curing dental restorative materials, 2. Assisting in the whitening process in dental office.

Source page: https://510kreport.com/device/K983654
Methodology: https://510kreport.com/methodology