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PicoWay Laser System

by Syneron Candela Corporation EUDAMED510(k)

Active European Union and United States

510(k) K162454

Overview

The PicoWay Laser System is a fractional photothermolysis device designed for non-ablative skin resurfacing and tissue remodeling. It delivers picosecond laser pulses to target collagen and elastin fibers, promoting skin tightening, reduction of fine lines, and improvement of skin texture and tone without removing the epidermis.

This system is intended for use in clinical settings by trained professionals and is supplied as a reusable medical device. It operates under FDA 510(k) clearance (K162454) and complies with the Medical Device Directive (MDD). The device is not single-use and requires proper maintenance, calibration, and storage as per manufacturer guidelines to ensure safety and performance.

AI-generated from registry data, 18 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK162454 Date1 Feb 2017ClearedStatusActive
European UnionCE/MDD EUDAMED Number— Date—StatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/MDD Expiring
  • United States FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

EUDAMED · 510(k)

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

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Questions

  • What types of skin concerns is the PicoWay Laser System specifically designed to address?

    The PicoWay Laser System is designed for non-ablative skin resurfacing and tissue remodeling, targeting collagen and elastin fibers to improve skin texture, tone, and tightness. It is particularly suited for addressing fine lines, wrinkles, and overall skin rejuvenation without damaging the epidermis.

  • Is the PicoWay Laser System intended for single-use or reusable in a clinical setting?

    The PicoWay Laser System is explicitly labeled as a reusable medical device, meaning it is meant to be used repeatedly in clinical settings by trained professionals. Proper maintenance, calibration, and storage are required to ensure its safety and performance over time.

  • How is the PicoWay Laser System regulated, and what does that mean for its use?

    The PicoWay Laser System holds FDA 510(k) clearance (K162454) and complies with the Medical Device Directive (MDD). This means it has undergone regulatory review to demonstrate substantial equivalence to a legally marketed device, ensuring it meets safety and effectiveness standards for use in clinical settings by trained professionals.

  • What kind of professional training is required to operate the PicoWay Laser System?

    The PicoWay Laser System is intended for use in clinical settings by trained professionals, though the specific training requirements are not detailed in the provided data. Typically, such devices require operators to have experience in dermatology, plastic surgery, or related fields, along with proper certification in laser safety and operation.