LinScan 808, LinScan 980

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K141063

Identifiers

510(k) Number: K141063 FDA 510(k)
FDA Product Code: GEX FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 878.4810 FDA 510(k)
Regulation Number: 878.4810 FDA 510(k)
Advisory Committee: General, Plastic Surgery FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

The LinScan 808 and LinScan 980 are handheld excimer pulsed light devices designed for dermatological and aesthetic treatments. These devices utilize specialized linear scanning technology to deliver precise, controlled energy for hair removal across various skin types, with three optimized treatment modes to enhance effectiveness and patient comfort.

Supplied as reusable medical devices, the LinScan 808 and LinScan 980 are intended for use in clinical settings under professional supervision. Both models are authorized under FDA 510(k) clearance (K141063) and comply with the Medical Device Directive (MDD). They are classified under product code GEX and fall under the General, Plastic Surgery advisory committee category, with no third-party review involved.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Linscan - GME | German Medical Engineering, GME LINSCAN 808 USER MANUAL Pdf Download | ManualsLib, Home - GME | German Medical Engineering, 510 (k) K141063 — LINSCAN 808, LINSCAN 980 — RegDataLab, LINSCAN 808, LINSCAN 980 510 (k) K141063 - FDA.report

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDD	—	Class II	Active
FDA 510(k)	United States	FDA_510K	K141063	Class II	Active

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Manufacturer

Manufacturer: GME German Medical Engineering GmbH
FDA Applicant: Gme (German Medical Engineering) GmbH

Sources (2)

FDA 510(k) K141063 24 fields · synced Sep 18, 2026
EUDAMED 1 fields · synced May 19, 2026