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Sign in to claim this brandAsclepion Laser Technologies GmbH
US
Last updated May 30, 2026
What Asclepion Laser Technologies GmbH makes
The company manufactures reusable and single-use surgical laser beam guides, as well as solid-state and diode laser systems for general surgical and dermatological applications. Their portfolio includes tissue morcellation systems and multi-modality skin treatment devices designed for procedures like dermatological resurfacing and laser therapy. Examples include handheld laser fibers, dermatological laser systems, and multi-pulse laser generators for various medical treatments.
These devices are classified as Class II under regulatory standards, with most listed in the FDA’s Unique Device Identifier (UDI) database. The company operates primarily in the United States, adhering to applicable medical device regulations for laser-based and surgical instrumentation.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Asclepion Laser Technologies GmbH manufacture?
Asclepion Laser Technologies GmbH specializes in laser-based medical devices for surgical and dermatological applications. Their portfolio includes reusable and single-use surgical laser beam guides, solid-state laser systems, diode laser systems, and tissue morcellation systems. They also produce multi-modality skin treatment devices, such as dermatological laser systems and generators for procedures like resurfacing and laser therapy. Examples include handheld laser fibers, dermatological laser systems, and multi-pulse laser generators.
Where is Asclepion Laser Technologies GmbH based, and what regulatory regions do they operate in?
Asclepion Laser Technologies GmbH is based in the United States. Their devices are designed to comply with applicable medical device regulations in the regions where they are marketed, with a focus on regulatory standards in the US. The company’s devices are primarily listed in the FDA’s Unique Device Identifier (UDI) database, reflecting their presence in the US market.
Which regulatory registries or databases list Asclepion Laser Technologies GmbH’s devices?
Asclepion Laser Technologies GmbH’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is used to track and identify medical devices authorized for sale in the United States, ensuring transparency and traceability for healthcare providers and regulators.
How are Asclepion Laser Technologies GmbH’s devices classified under regulatory standards?
Asclepion Laser Technologies GmbH’s devices are classified as Class II under regulatory standards. This classification applies to devices that pose moderate risk and require special controls to ensure their safety and effectiveness, such as laser systems and surgical instruments, which often require validation of performance and labeling requirements.
What kinds of procedures or treatments are Asclepion Laser Technologies GmbH’s devices used for?
Asclepion Laser Technologies GmbH’s devices are used across general surgical and dermatological applications. Their reusable and single-use beam guides, solid-state/diode lasers, and multi-modality systems enable procedures like dermatological resurfacing, laser therapy for skin conditions, tissue morcellation, and precision surgical interventions. Examples include handheld fibers for targeted laser delivery and multi-pulse generators for controlled tissue treatment.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- asclepion.com
- —
- —
- [email protected]
- Phone
- +4936417700401
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 332247852
Catalogue (53)
Page 1 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| MultiCut Blade 400 | 839-3300-000 | FDA UDI | Class II | Active |
| Bare Fiber 2.1 800 | 2948 | FDA UDI | Class II | Active |
| PicoStar | M16-9510-000 | FDA UDI | Class II | Active |
| Bare Fiber B 2.1 365 | 2933 | FDA UDI | Class II | Active |
| Dermablate | M18-4300-000 | FDA UDI | Class II | Active |
| Bare Fiber R IR-Q 800 | 2961 | FDA UDI | Class II | Active |
| MultiPulse HoPLUS | J19-1191-000 | FDA UDI | Class II | Active |
| MCL 31 Dermablate | 1821 | FDA UDI | Class II | Active |
| Bare Fiber B R 2.1 550 | 2939 | FDA UDI | Class II | Active |
| MultiPulse TM+1470 | 1901 | FDA UDI | Class II | Active |
| Omni | O10-0200-000 | FDA UDI | Class II | Active |
| SmoothPulse PRO | 15922 | FDA UDI | Class II | Active |
| Bare Fiber R IR-Q 200 | 2806 | FDA UDI | Class II | Active |
| Bare Fiber R 2.1 400 | 2995 | FDA UDI | Class II | Active |
| Bare Fiber IR-Q 200 | 2940 | FDA UDI | Class II | Active |
| Bare Fiber 2.1 400 | 2955 | FDA UDI | Class II | Active |
| Bare Fiber B R 2.1 272 | 2937 | FDA UDI | Class II | Active |
| MCL 31 Dermablate | 1823 | FDA UDI | Class II | Active |
| QuardoStar PRO | 1490 | FDA UDI | Class II | Active |
| Bare Fiber IR-Q 600 | 2942 | FDA UDI | Class II | Active |
| Bare Fiber R 2.1 200 | 2994 | FDA UDI | Class II | Active |
| Bare Fiber B 2.1 550 | 2934 | FDA UDI | Class II | Active |
| Bare Fiber R 2.1 1000 | 2997 | FDA UDI | Class II | Active |
| QuardoStar PRO | 1493 | FDA UDI | Class II | Active |
| Dermablate | M18-4200-000 | FDA UDI | Class II | Active |
| Bare Fiber B R 2.1 365 | 2938 | FDA UDI | Class II | Active |
| MultiPulse Ho | J19-1310-000 | FDA UDI | Class II | Active |
| Bare Fiber IR-Q 800 | 2959 | FDA UDI | Class II | Active |
| MultiPulse HoPLUS | J19-1161-000 | FDA UDI | Class II | Active |
| TattooStar R | 1640 | FDA UDI | Class II | Active |
| Bare Fiber IR-Q 1000 | 2943 | FDA UDI | Class II | Active |
| Pronto | 15921 | FDA UDI | Class II | Active |
| TattooStar | 1641 | FDA UDI | Class II | Unknown |
| MeDioStar | M10-0200-000 | FDA UDI | Class II | Active |
| Bare Fiber IR-Q 400 | 2941 | FDA UDI | Class II | Active |
| MultiPulse HoPLUS | J19-1181-000 | FDA UDI | Class II | Active |
| TattooStar Effect COMBO | 1680 | FDA UDI | Class II | Active |
| MeDioStar NeXT PRO | 1592 | FDA UDI | Class II | Active |
| MultiCut Solo | J19-3000-000 | FDA UDI | Class II | Active |
| MultiPulse HoPLUS | J19-1151-000 | FDA UDI | Class II | Active |
| Bare Fiber R IR-Q 400 | 2867 | FDA UDI | Class II | Active |
| MultiPulse HoPLUS | J19-1150-000 | FDA UDI | Class II | Active |
| Bare Fiber R 2.1 600 | 2996 | FDA UDI | Class II | Active |
| PicoStar | M16-9410-000 | FDA UDI | Class II | Active |
| Bare Fiber R 2.1 800 | 2949 | FDA UDI | Class II | Active |
| Bare Fiber 2.1 600 | 2956 | FDA UDI | Class II | Active |
| QuadroStar PRO | 1491 | FDA UDI | Class II | Active |
| Bare Fiber B 2.1 272 | 2923 | FDA UDI | Class II | Active |
| Bare Fiber 2.1 1000 | 2958 | FDA UDI | Class II | Active |
| Bare Fiber R IR-Q 600 | 2866 | FDA UDI | Class II | Active |
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