# K022837: Fotona Tandem Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Fotona D.D.
- Decided: Nov 25, 2002 after 90 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) Fotona Dualis long pulse KTP laser system: named in the summary without a submission number
- (no number) Fotona Dualis Nd:YAG laser system: named in the summary without a submission number
- (no number) Palomar Clear Light Nd:YAG laser system, marketed under Palomar Q-YAG 5: named in the summary without a submission number

## Indications for use
The Fotona Tandem Laser System and Accessories is intended for incision, ablation, vaporization, coagulation, and hemostasis of vascular lesions and soft tissue in various surgical areas, and for permanent hair reduction in Fitzpatrick skin types I-VI. KTP Laser (532 + 1064 nm) The Fotona Tandem KTP laser is intended for incision, ablation, vaporization, coagulation, and hemostasis of vascular lesions and soft tissue in various surgical areas. All soft tissue is included, such as skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs, and glands. Dermatoloqy : The treatment (hemostasis, color lightening, blanching, flattening, reduction of lesion size) of the vascular lesions (Angiomas, Hemangiomas, Telangiectasia) Nd:YAG Laser (1064 nm) The Tandem Nd:YAG laser systems is indicated for use in surgical and aesthetic applications requiring selective photothermolysis of target chromophores in soft tissue in the medical specialities of general and plastic surgery and dermatology: To effect stable long-term, or permanent, hair reduction in skin types I - VI through selective targeting of melanin in hair follicles. Permanent hair reduction is defined a:; a long-term stable reduction in the number of hairs regrowing after a treatment regimen. For removal of unwanted hair. For coagulation and hemostasis of vascular lesions. For incision/excision of soft body tissue in dermatology. For soft tissue general surgery applications - skin incision; tissue dissection; complete or partial resection of internal organs, tumors, lesions; tissue ablation; vessel coagulation.

Source page: https://510kreport.com/device/K022837
Methodology: https://510kreport.com/methodology