PicoWay Laser System

Syneron-Candela

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

Product code GEX· 21 CFR 878.4810

View Summary PDF

Company

United States (US)

Product code

GEX
21 CFR 878.4810

Predicate devices

13

Cited as predicate

3

Device details

FDA 510(k) registration fields

K number
K162454
Device name
PicoWay Laser System
Country / region
United States(US)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2016-09-01
Decision date
2017-02-01
Submission type
Traditional
Technology type
Picosecond(AI inferred)
Clinical applications
Pigment treatment
Primary application
Pigment treatment
Classification source
AI classified

Indications for Use

The PicoWay laser system is indicated for the following at the specified wavelength:

532nm: Removal of tattoos for Fitzpatrick skin types I-III to treat the following tattoo colors: red, yellow and orange.

785nm: Removal of tattoos for Fitzpatrick skin types II-IV to treat the following tattoo colors: green and blue.

1064nm: Removal of tattoos for all skin types (Fitzpatrick I-VI) to treat the following tattoo colors: black, brown, green, blue and purple.

The PicoWay laser system is also indicated for benign pigmented lesions removal for Fitzpatrick Skin Types I-IV.

The Resolve handpiece (1064 nm) is also indicated for the treatment of acne scars in Fitzpatrick Skin Types II-V.

Intended Use

The PicoWay laser system is indicated for the following at the specified wavelength: 532nm: Removal of tattoos for Fitzpatrick skin types I-III to treat the following tattoo colors: red, yellow and orange. 785nm: Removal of tattoos for Fitzpatrick skin types II-IV to treat the following tattoo colors: green and blue. 1064nm: Removal of tattoos for all skin types (Fitzpatrick I-VI) to treat the following tattoo colors: black, brown, green, blue and purple. The PicoWay laser system is also indicated for benign pigmented lesions removal for Fitzpatrick Skin Types I-IV. The Resolve handpiece (1064 nm) is also indicated for the treatment of acne scars in Fitzpatrick Skin Types II-V.

Device Description

The PicoWay Laser System is a solid state laser capable of delivering energy at wavelengths of 1064 nm, 785 nm, or 532 nm at short durations of 240–540 picoseconds (ps) at repetition rates up to 10 Hz (1064 nm, 532 nm) or 5 Hz (785 nm). The device system is comprised of a system console, an articulated arm, and an attached Zoom or Resolve Handpiece. The laser output at each wavelength is generated within the laser chassis and delivered to the skin through an articulated arm delivery system terminated by a Handpiece. The light-weight and ergonomic Zoom Handpieces allow the spot size on the skin to be easily adjusted. A range of spot sizes is available for the PicoWay System when using the Zoom Handpiece (up to 10 mm). The Resolve Handpieces are available with 6 x 6 mm spot size for both wavelengths. The system includes an internal calibration port with an internal meter located on the control panel of the system console, which is used to verify the transmission of the laser beam into the articulated arm. The PicoWay system control panel enables the user to select the desired energy density level and repetition rate. The control panel is also used to obtain feedback from the system, such as the number of pulses delivered or spot size selected.

Summary parsed at:2026-06-01 05:58:50 UTC

Predicate devices

13

K162454 references 13 predicate/reference devices

Cited as predicate

3

3 submissions cite K162454 as a predicate