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PicoWay Laser System

by Candela Corporation EUDAMED510(k)GUDID

Active United States and European Union

Ref 9914-40-9060Model PicoWay Laser System

Overview

The PicoWay Laser System is a fractional picosecond laser device (Nomenclature Code: Z12011006) designed for non-ablative skin resurfacing and tissue remodeling. It delivers ultra-short pulsed energy to stimulate collagen production, improve skin texture, and treat conditions such as acne scars, pigmentation, and fine lines by inducing controlled micro-injuries in the skin.

This non-sterile, non-reusable device (Reference: 9914-40-9060) is intended for use in clinical settings by trained professionals. Supplied as a single-use system, it requires proper handling and storage per manufacturer instructions. The PicoWay Laser System holds FDA 510(k) clearance under the Medical Device Data System (MDD) and is classified as Class IIb, with no implantable or medicinal product components. Compliance with regulatory standards ensures safe operation in aesthetic and dermatological procedures.

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

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00817495021393 Basic UDI-DIDate6 Mar 2026RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK220853 Date13 Oct 2022IssuedStatusActive
United StatesGUDID listing GUDID Number00817495021393 UDI-DIDate23 Sep 2016ListedStatusIn distribution

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
  • United States FDA 510(k) Active
  • European Union CE/MDD Expiring

Recalls: none on record (FDA, checked 25 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · 510(k) · GUDID

Trade Name
PicoWay Laser System EUDAMED
PicoWay GUDID
Generic Name
Dermatological frequency-doubled solid-state laser system
Model / Reference
PicoWay Laser System, 9914-40-9060
Primary DI / UDI-DI
00817495021393
Basic UDI-DI
B-00817495021393
510(k) Number
FDA Product Code
GEX
EMDN Code
Z12011006 Diode–pumped solid–state (dpss) surgical laser
GMDN Term
Dermatological frequency-doubled solid-state laser system
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
878.4810
Market of Registration
Belgium
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000022750
Authorised representative
AR Experts B.V. NL-AR-000023989

Other devices from Candela Corporation

See all devices from Candela Corporation →

Questions

  • What types of skin conditions is the PicoWay Laser System primarily used to treat?

    The PicoWay Laser System is designed for non-ablative skin resurfacing and tissue remodeling, targeting conditions like acne scars, pigmentation issues, and fine lines. It works by delivering ultra-short pulsed energy to stimulate collagen production and improve skin texture through controlled micro-injuries.

  • Is the PicoWay Laser System reusable or single-use, and how should it be handled?

    The PicoWay Laser System is a single-use device, meaning each system is intended for one procedure only. Since it is non-sterile and non-reusable, proper handling and storage per the manufacturer’s instructions are required to ensure safety and efficacy in clinical settings.

  • What regulatory pathway did the PicoWay Laser System follow to gain clearance, and what class does it belong to?

    The PicoWay Laser System received FDA clearance through a 510(k) submission under the Medical Device Data System (MDD), classified as Class IIb. The decision was based on substantial equivalence to a predicate device, with no implantable or medicinal components involved.

  • How is the PicoWay Laser System supplied, and what should clinicians consider regarding sterility?

    The PicoWay Laser System is supplied as a non-sterile, single-use system. Clinicians should follow Candela Corporation’s guidelines for proper handling and storage, as the device is not intended for reuse or sterilization between procedures.

  • Who is the manufacturer of the PicoWay Laser System, and how can I contact them for support?

    The PicoWay Laser System is manufactured by Candela Corporation, headquartered at 251 Locke Dr., Marlborough, MA 01752, USA. For inquiries, you may contact Danielle Gibboney, though official support channels should be verified through Candela’s official communications.

Properties

Show properties
  • Prescription Use
  • Serial Number
  • Manufacturing Date
Other properties (19)
  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No