Picosure Workstation

Cynosure, LLC

Country / region:United States (US)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Company

United States (US)

Product code

GEX
21 CFR 878.4810

Predicate devices

3

Cited as predicate

5

Device details

FDA 510(k) registration fields

K number
K143105
Device name
Picosure Workstation
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

3

K143105 references 3 predicate/reference devices

Cited as predicate

5

5 submissions cite K143105 as a predicate