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
- K173199
- 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
- 2017-10-02
- Decision date
- 2018-02-07
- Submission type
- Traditional
- Technology type
- Picosecond(AI inferred)
- Clinical applications
- Pigment treatmentAcne treatment
- 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 2mm 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 delivery system is indicated for tattoo removal and benign pigmented lesion removal in Skin Types I-III. The PicoSure 1064 nm Laser Delivery System is indicated for tattoo and benign pigmented lesions removal.
Intended Use
The PicoSure Workstation is indicated for tattoo and benign pigmented lesions removal. The PicoSure workstation with the 2mm 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 delivery system is indicated for tattoo removal and benign pigmented lesion removal in Skin Types I-III. The PicoSure 1064 nm Laser Delivery System is indicated for tattoo and benign pigmented lesions 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 755nm handpiece, optional 532nm Laser Delivery System and/or 1064nm Laser Delivery System can replace the 755nm handpiece at the distal end of the articulated arm. These Delivery Systems convert the 755nm laser energy into a 532nm wavelength or a 1064 nm wavelength, and are available in multiple spot sizes.
Summary parsed at:2026-06-01 05:56:29 UTC
Predicate devices
2—
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Not ingested
PicoSure Workstation
K173199 references 2 predicate/reference devices
Cited as predicate
3enlighten III Laser System
StarWalker
PicoSure Workstation
3 submissions cite K173199 as a predicate
