# K031488: Cynosure Apogee-TKS II Dermatological Laser

- Pathway: 510(k) (Traditional)
- Applicant: Cynosure, Inc.
- Decided: Jun 4, 2003 after 23 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.
142 later devices descend from it; 4 cite it directly.
0 of 143 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-TKS: named in the summary without a submission number

## Most influential descendants
- K043251: Candela Family of Pulsed Dye Laser Systems, Models Vbeam, Cbeam, SPTL-1B (2005), 136 descendants of its own
- K050673: Candela Family of Pulse Dye Laser Systems (2005), 133 descendants of its own
- K070388: Profile Multi-Platform System (2007), 129 descendants of its own
- K042474: ARION (2004), 114 descendants of its own
- K081352: Profile Multi-Platform System (2008), 112 descendants of its own

## Indications for use
The Cynosure Apogee-TKS I1 Dermatological Laser is indicated for stable long-term, or permanent hair reduction. Permanent hair reduction is defined as long-term stable reduction in the number of hair regrowth after a treatment regime. It is used for all skin types (Fitzpatrick I - VI) including tanned skin. It is also indicated for the treatment of vascular lesions, benign pigmented lesions, and wrinkles.

Source page: https://510kreport.com/device/K031488
Methodology: https://510kreport.com/methodology