# K034030: Apogee Elite

- Pathway: 510(k) (Traditional)
- Applicant: Cynosure, Inc.
- Decided: Feb 9, 2004 after 42 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.
252 later devices descend from it; 14 cite it directly.
0 of 253 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
- (no number) Cynosure Acclaim: named in the summary without a submission number

## Most influential descendants
- K063074: Candela 3630 Laser System (2006), 179 descendants of its own
- K073534: Candela Family of Q-Switched Alexandrite Laser (Alexlazr) Systems (2008), 113 descendants of its own
- K081352: Profile Multi-Platform System (2008), 112 descendants of its own
- K081324: Candela Family of Q-Switched Alexandrite Lasers (2008), 112 descendants of its own
- K101916: Joule Multi-Platform System (2011), 111 descendants of its own

## Indications for use
The Cynosure Apogee Elite 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. The Cynosure Apogee Elite Dermatological laser is intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiornas, warts, telangiectasia, rosacea, venus lake, leg veins, spider veins and poikiloderma of civatte; and treatment of benign cutaneous lesions such as warts, scars, striae and psoriasis. The laser is also intended for the treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), cafr' au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue/black tattoos) and plaques. The laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles. Additionally, the laser is indicated for the removal of unwanted hair, for the stable long term, or permanent, hair reduction through selective targeting of melanin in hair follicles, and for the treatment of pseudofolliculitis barbae (PFB).

Source page: https://510kreport.com/device/K034030
Methodology: https://510kreport.com/methodology