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Slim Evolution Family of CO2 Lasers and Delivery Device Accessories

by Lasering s.r.l.

510(k) K063001Ref AT0231Model SLIM EVOLUTION

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K063001↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number805647709SLIMEVO47 Basic UDI-DI 08056477090008UDI-DIDate28 Aug 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number08056477090008 UDI-DI Date13 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK063001 Date7 Mar 2007ClearedStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k) · GUDID

Trade Name
Slim Evolution EUDAMED
Lasering SRL GUDID
Generic Name
Dermatological carbon dioxide laser system
Model / Reference
SLIM EVOLUTION, AT0231
Primary DI / UDI-DI
08056477090008
Basic UDI-DI
805647709SLIMEVO47
Direct Marketing DI
08056477090008
510(k) Number
FDA Product Code
GEX
EMDN Code
Z12011005 Carbon dioxide surgical laser
GMDN Term
Dermatological carbon dioxide laser system
Device Class
Class IIb EUDAMED
Class II 510(k)GUDID
Regulation
21 CFR Part 878.4810
EU market of registration
Italy
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent
GUDID distribution status
In Commercial Distribution

Truth per registry

3 sources · 1 field differs

FieldEUDAMED510(k)GUDID
Device ClassEUDAMED
Class IIb
510(k)
Class II
GUDID
Class II

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Slim Evolution Family of CO₂ Lasers and Delivery Device Accessories is a class of carbon dioxide laser systems designed for precise tissue ablation and coagulation. These devices are primarily used in dermatological and plastic surgery procedures, including skin resurfacing, lesion removal, and soft tissue sculpting, leveraging high-energy CO₂ laser beams for controlled thermal effects.

The system is supplied as a modular family of CO₂ lasers paired with specialized delivery accessories, intended for single-use or reusable components as specified by the manufacturer. Authorized under FDA 510(k) clearance (K063001) and MDR compliance, the devices are intended for use in clinical settings where sterile conditions are maintained. Accessories may vary in design for specific procedural applications, and storage requirements align with standard laser equipment protocols to preserve functionality and safety.

Other devices from Lasering s.r.l.

Properties

  • Serial Number
  • Manufacturing Date

Other properties (22)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No