TwinScan 808/755 Laser System
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K192269 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 TwinScan 808/755 Laser System is a laser surgical instrument classified under 21 CFR 878.4810 for use in general and plastic surgery and dermatology. It is designed for hair removal and permanent hair reduction, delivering stable, long-term reduction in hair counts at specified follow-up intervals (6, 9, or 12 months). The device combines dual-wavelength laser technology (808 nm and 755 nm) to target hair follicles effectively while minimizing damage to surrounding tissue.
This system is supplied as a reusable medical device and is intended for use in clinical settings by trained professionals. It has received FDA 510(k) clearance under the Medical Device Directive (MDD) and is classified as substantially equivalent to existing predicate devices. The device requires proper handling, calibration, and maintenance to ensure safety and efficacy, adhering to regulatory standards for laser surgical instruments. No specific sterility claims are stated in the provided data.
Frequently asked questions
What types of procedures is the TwinScan 808/755 Laser System primarily used for in clinical settings?
The TwinScan 808/755 Laser System is designed specifically for hair removal and permanent hair reduction procedures in general and plastic surgery, as well as dermatology. Its dual-wavelength technology (808 nm and 755 nm) targets hair follicles to achieve stable, long-term reductions in hair counts, with follow-up assessments at intervals of 6, 9, or 12 months.
Is the TwinScan 808/755 Laser System intended for single-use or reusable applications, and what does this mean for maintenance?
The TwinScan 808/755 Laser System is classified as a reusable medical device, meaning it is meant for repeated use in clinical settings by trained professionals. This requires adherence to proper handling, calibration, and maintenance protocols to ensure safety and efficacy, as outlined in regulatory standards for laser surgical instruments.
What regulatory pathway was followed for the TwinScan 808/755 Laser System, and what does this mean for its use?
The TwinScan 808/755 Laser System received FDA 510(k) clearance under the Medical Device Directive (MDD) and was determined to be substantially equivalent to existing predicate devices. This classification means it meets regulatory standards for laser surgical instruments and is approved for use in clinical settings by trained professionals, adhering to the guidelines outlined in 21 CFR 878.4810.
How does the TwinScan 808/755 Laser System differ from other laser systems in terms of its technology?
The TwinScan 808/755 Laser System combines dual-wavelength laser technology (808 nm and 755 nm), which allows it to target hair follicles more effectively while minimizing damage to surrounding tissue. This dual-wavelength approach is intended to enhance the device’s efficacy for hair removal and permanent hair reduction procedures.
Who is the manufacturer of the TwinScan 808/755 Laser System, and how can I contact them for support or inquiries?
The TwinScan 808/755 Laser System is manufactured by GME German Medical Engineering GmbH, located at Grimmstrasse 23, Nuremberg, Germany. For support or inquiries, you can contact Stefan Schulze, who serves as the point of contact for the manufacturer.
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: PDF GME German Medical Engineering GmbH ℅ Mike Johnson Consultant ..., TwinScan 808/755 Laser System (K192269) — FDA 510(k) | Innolitics, TwinScan 808/755 Laser System (K192269) - FDA 510 (k), Home - GME | German Medical Engineering
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K192269 | Class II | Active |
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Manufacturer
- Manufacturer
- GME German Medical Engineering GmbH
Sources (2)
- FDA 510(k) K192269 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026