# K992757: Cynosure Apogee-TKS Dermatological Laser

- Pathway: 510(k) (Traditional)
- Applicant: Cynosure, Inc.
- Decided: Jun 29, 2000 after 318 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.
340 later devices descend from it; 8 cite it directly.
0 of 341 devices 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) Cynosure Apogee Laser: named in the summary without a submission number

## Most influential descendants
- K020849: Apex 800 Laser System, Model Apex 800 (2002), 174 descendants of its own
- K032846: Spectra Pulsed Diode Laser, Model DR-1 (2003), 173 descendants of its own
- K052848: Spectra Hair Removal Laser (2005), 172 descendants of its own
- K060839: Abc Hair Removal System (2006), 171 descendants of its own
- K053527: Spectra Hair Removal Laser (2008), 169 descendants of its own

## Indications for use
The Cynosure Apogee-TKS laser is indicated for vascular lesion removal and stable, long-term, or permanent hair reduction. Permanent hair reduction is defined as long-term, stable reduction in the number of hairs re-growing after a treatment regime. The number of hairs re-growing must be stable over a time greater than the duration of the complete growth cycle of hair follicles, which varies from 4-12 months according to body location. Permanent hair reduction does not necessarily imply the elimination of all hairs in the treated area.

Source page: https://510kreport.com/device/K992757
Methodology: https://510kreport.com/methodology