Manufacturer
Rohrer AestheticsPicoLazer Laser System
Country / Region:United States (US)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K192583
- Device name
- PicoLazer Laser System
- Company
- Rohrer Aesthetics
- Country / Region
- United States(US)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2019-09-19
- Decision date
- 2020-01-17
- Submission type
- Traditional
- Technology type
- Picosecond(AI inferred)
- Clinical applications
- Pigment treatmentSurgical cutting
- Primary application
- Pigment treatment
- Classification source
- AI classified
Indications for Use
The PicoLazer laser system is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery. 1064 nm The 1064 nm wavelength of the PicoLazer laser system is indicated for: • treatment of benign pigmented lesions on patients with all skin types (Fitzpatrick I-VI) • tattoo removal for dark colored tattoo inks and for multicolored tattoos containing dark colored tattoo inks on patients with all skin types (Fitzpatrick I-VI) 532 nm The 532 nm wavelength of the PicoLazer laser system is indicated for: • treatment of benign pigmented lesions on patients with Fitzpatrick skin types I-III • tattoo removal for lighter colored tattoo inks, including red and yellow inks, on patients with Fitzpatrick skin types I-III
Intended Use
The PicoLazer laser system is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery.
Device Description
The PicoLazer Laser System is a multi-wavelength laser system that operates at 1064 nm and 532 nm wavelengths. The 1064 nm wavelength is indicated for the treatment of benign pigmented lesions and tattoo removal for dark colored tattoo inks on patients with all skin types (Fitzpatrick I-VI). The 532 nm wavelength is indicated for the treatment of benign pigmented lesions and tattoo removal for lighter colored tattoo inks on patients with Fitzpatrick skin types I-III.
Summary parsed at:2026-06-01 05:46:54 UTC
Predicate devices
2PicoWay Laser System
Picocare Family
K192583 references 2 predicate/reference devices
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K192583 as a predicate