PicoWay Laser System
by Syneron Candela Corporation EUDAMED510(k)
Active
510(k) K160607
Overview
The PicoWay Laser System is a picosecond laser device classified under the nomenclature for laser-based skin resurfacing and tattoo removal. It employs ultra-short pulse technology to target and break down pigmented lesions, tattoos, acne scars, and fine wrinkles with high precision, minimizing collateral tissue damage.
This system is supplied as a reusable medical device and is intended for use in clinical settings by trained professionals. It includes interchangeable handpieces and wavelengths optimized for specific indications, with no specified sterility requirements beyond standard pre-procedural cleaning protocols. The device carries FDA 510(k) clearance under the General, Plastic Surgery advisory committee and complies with the Medical Device Directive (MDD).
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK160607 | Date5 Jul 2016 | StatusActive |
| European Union | CE/MDD EUDAMED | Number— | Date— | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- GEX
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4810
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Other devices from Syneron Candela Corporation
Questions
What clinical conditions is the PicoWay Laser System primarily designed to treat, and how does its technology differ from traditional lasers?
The PicoWay Laser System is specifically designed for skin resurfacing and tattoo removal, targeting pigmented lesions, tattoos, acne scars, and fine wrinkles. Unlike traditional lasers that rely on continuous or long-pulse energy, PicoWay uses ultra-short picosecond pulses to break down targeted tissue with high precision while minimizing damage to surrounding skin. This technology reduces collateral thermal injury, making it suitable for delicate areas and sensitive skin types.
Is the PicoWay Laser System single-use or reusable, and what cleaning protocols should be followed?
The PicoWay Laser System is reusable and intended for use in clinical settings by trained professionals. Since it is not sterile out-of-the-box, standard pre-procedural cleaning protocols must be followed per manufacturer guidelines to ensure safety and hygiene. Interchangeable handpieces may require similar cleaning between uses, but no specific sterility requirements beyond this are stated.
What regulatory pathways has the PicoWay Laser System undergone, and which advisory committee was involved?
The PicoWay Laser System received FDA 510(k) clearance under the General, Plastic Surgery advisory committee (SU) as substantially equivalent to a predicate device. It also complies with the Medical Device Directive (MDD) in the EU. The clearance was granted in 2016 after review by Syneron Candela Corporation, with the submission filed under product code GEX and decision code SESE.
Does the PicoWay Laser System come with interchangeable components, and if so, what are they used for?
Yes, the PicoWay Laser System includes interchangeable handpieces designed for different clinical applications. These handpieces are optimized for specific wavelengths and treatment targets—such as tattoo removal, pigmented lesions, or skin resurfacing—allowing clinicians to select the appropriate tool based on the patient’s needs and the procedure being performed.