Manufacturer
Cynosure, LLCPicosure Workstation
Country / Region:United States (US)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Device details
FDA 510(k) registration fields
- K number
- K143105
- Device name
- Picosure Workstation
- Company
- Cynosure, LLC
- Country / Region
- United States(US)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2014-10-29
- Decision date
- 2015-02-23
- Submission type
- Traditional
- Technology type
- Picosecond(AI inferred)
- Clinical applications
- Pigment treatmentAcne treatmentSkin resurfacing
- Primary application
- Pigment treatment
- Classification source
- AI classified
Indications for Use
The PicoSure workstation is indicated for tattoo and benign pigmented lesions removal. The PicoSure workstation with the 3mm and 6mm handpieces and the Focus Array are indicated for the treatment of acne scars and wrinkles in Skin Types I-IV. The PicoSure 532 nm Laser Delivery System is indicated for tattoo removal.
Intended Use
The PicoSure workstation is indicated for tattoo and benign pigmented lesions removal. The PicoSure workstation with the 3mm and 6mm handpieces and the Focus Array are indicated for the treatment of acne scars and wrinkles in Skin Types I-IV. The PicoSure 532 nm Laser Delivery System is indicated for tattoo removal.
Device Description
The PicoSure™ workstation is a high-powered, Alexandrite system that delivers laser energy in the 755-nm nominal wavelength. The system offers fast and efficient treatment through a variety of spot sizes, fluences and repetition rates. Laser activation is by footswitch. In addition to the 755 nm handpiece, an optional 532 nm Laser Delivery System can replace the 755 nm handpiece at the distal end of the articulated arm. This 532 nm Laser Delivery System converts the 755 nm laser energy into a 532 nm wavelength and is available in multiple spot sizes.
Summary parsed at:2026-06-01 06:10:33 UTC
Predicate devices
3Cited as predicate
5PicoWay Laser System
PicoSure Workstation
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5 submissions cite K143105 as a predicate