Cyber-Lase 2000 Curing and Whitening Laser

by Ics of North America, Inc. 510(k)

Active United States

510(k) K983654

Regulatory status

as of 29 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK983654	Date12 Jan 1999Cleared	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number: K983654
FDA Product Code: GEX

Device Class: Class II
Regulation: 21 CFR Part 878.4810
Advisory Committee: General, Plastic Surgery
FDA Decision: SESE Substantially Equivalent

Other devices from Ics of North America, Inc.

Easy-Cure (Curing and Whitening Light)

Class II