Product code GEX· 21 CFR 878.4810
Product code
Cited as predicate
FDA 510(k) registration fields
The PL-1 Skin Treatment System is a 1064 nm laser system intended to ablate, vaporize, and coagulate soft body tissues for aesthetic and cosmetic applications in the medical specialties of dermatology and plastic surgery. It is also indicated for removal of benign pigmented lesions including; nevus of Ota, café au lait spot, ephelides, solar lentigo (lentigines), Becker's nevus, nevus spilus and treatment of common nevi. The PL-1 Skin Treatment System is intended to be used by medical professionals and staff who are trained in the use of lasers and who are familiar with the technology, operation of the system, and safety precautions.
The PL-1 Skin Treatment System is a 1064 nm laser system intended to ablate, vaporize, and coagulate soft body tissues for aesthetic and cosmetic applications in the medical specialties of dermatology and plastic surgery. It is also indicated for removal of benign pigmented lesions including; nevus of Ota, caf6 au lait spot, ephelides, solar lentigo (lentigines), Becker's nevus, nevus spilus and treatment of common nevi. The PL-1 Skin Treatment System is intended to be used by medical professionals and staff who are trained in the use of lasers and who are familiar with the technology, operation of the system, and safety precautions.
The PL-1 Skin Treatment System is a 1064nm, Q-switched laser system. The system includes three (3) main components: Console, Tablet, and Handpiece. The Console houses the system control electronics, power distribution, contact cooling, and laser. The Tablet is the primary user interface for controlling the system through a touch screen graphical user interface. The Handpiece contains the optics, focusing components, and reference window assembly. The PL-1 Skin Treatment System is a software-controlled device. The operator enters treatment parameters on the Tablet and places the Handpiece on the treatment site. A treatment is initiated by the operator to cause laser energy to be projected into the skin of a patient. The device is intended to be used by a suitably trained professional in a clinical setting. There are no sterile components.
Summary parsed at:2026-06-01 05:39:12 UTC
Chrome
K213726 references 1 predicate/reference device
No later 510(k)s cite this device yet
Other submissions will appear here when they list K213726 as a predicate
