# K033176: Tristar Aesthetic Workstation Laser

- Pathway: 510(k) (Special)
- Applicant: Cynosure, Inc.
- Decided: Jan 21, 2004 after 112 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.
522 later devices descend from it; 4 cite it directly.
0 of 523 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) VLS-Star: named in the summary without a submission number
- (no number) PhotoGenica YAG lasers: named in the summary without a submission number

## Most influential descendants
- K042000: Modified MSQ Family of Lovely Light/Laser Systems (2004), 517 descendants of its own
- K072564: Alma Lasers Harmony XL Multi-Application Platform (2008), 266 descendants of its own
- K060033: Profile Multi-Platform System (2006), 221 descendants of its own
- K073063: 15W Ceralas D 1470NM Diode Laser (2008), 202 descendants of its own
- K083899: Revlite Q-Switched ND:Yag Laser System (2009), 198 descendants of its own

## Indications for use
585nm - 600nm: The TriStar Aesthetic Workstation laser is indicated for benign vascular and vascular dependent lesions removal. 1064nm: The TriStar laser is intended for the coagulation and hemostasis of benign vascular leasions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus laske, leg veins, spider veins and poikiloderma of civatte and treatment of benign cutaneous lesions such as but not limited to, lentigos (age spots), solar lentigos (sun spots), cafr au lait macules, seborrheic keratoses, nevi, chloasma, verrucea, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue/black tattoos) and plaques. The laser is also indicated for thiotreatment 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 tern, or permanent, hair reduction through selective targeting of melanin in hair follicles, and for the treatment of psuedofolliculitis barbae (PFB). 1320 nm: The TriStar laser is indicated for use in gental surgery and dermatology for the incision, excision, ablation, vaporization, coagulation and hemostasis of soft tissue. It is also indicated for the treatment of periorbital and perioral wrinkles. It is also indicated for the treatment of fine lines and wrinkles.

Source page: https://510kreport.com/device/K033176
Methodology: https://510kreport.com/methodology