# K022341: Terabyte 2000 Hair Remover

- Pathway: 510(k) (Traditional)
- Applicant: Terabyte Co.
- Decided: Jan 27, 2003 after 193 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.
No later device cites it as a predicate yet.
0 of 1 device 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) Coherent Inc., Light Sheer Family (Light Sheer SP, Light Sheer EP, Light Sheer SC, and Light Sheer EC): named in the summary without a submission number
- (no number) Cynosure Corp., Apogee 6200: named in the summary without a submission number
- (no number) Cynosure Corp., Apogee 9300: named in the summary without a submission number

## Indications for use
TERABYTE 2000 System is intended for hair removal and permanent hair reduction.

Source page: https://510kreport.com/device/K022341
Methodology: https://510kreport.com/methodology