Identity
- Trade Name
- Laserneedle Touch FDA UDI
- Generic Name
- Musculoskeletal/physical therapy laser, professional FDA UDI
- Device Name
- Touch OrthoPhys -Trolley version (12000). This device is Laserneedle Touch Orthophys with 5 Red (5R) and 5 Infra red (5IR) lasers. Under the scope of delivery of the Laserneedle device package are included the following accessories / consumables / spare parts: - Regular optical fiber (Product number: 40200; Primary DI number: 4260649160244) - Quartz optical fiber (Product number: 40300 Primary DI number: 4260649160275) - Trolley with power supply (Touch OrthoPhys -Trolley version (12000). This device is Laserneedle Touch Orthophys with 5 Red (5R) and 5 Infra red (5IR) lasers. Under the scope of delivery of the Laserneedle device package are included the following accessories / consumables / spare parts: - Regular optical fiber (Product number: 40200; Primary DI number: 4260649160244) - Quartz optical fiber (Product number: 40300 Primary DI number: 4260649160275) - Trolley with power supply (Product number: 35000 Primary DI number: 4260649160213) - Laser protection goggles (Product number: 32010 Primary DI number: 4260649160305) - LN Tape (Product number: 40100 Primary DI number: 4260649160466) - Self adhesive applicator (Product number: 40510 Primary DI number: 4260649160404) - LN Tip caps (Product number: 40710 Primary DI number: 4260649160503) - Set of silicon pads (Product number: 40600; Primary DI number: 4260649160312) - Silicone applicators (Product number: 40410; Primary DI number: 4260649160411) FDA UDI
- Model / Reference
- 12000-Trolley FDA UDI
- Description
- Touch OrthoPhys -Trolley version (12000). This device is Laserneedle Touch Orthophys with 5 Red (5R) and 5 Infra red (5IR) lasers. Under the scope of delivery of the Laserneedle device package are included the following accessories / consumables / spare parts: - Regular optical fiber (Product number: 40200; Primary DI number: 4260649160244) - Quartz optical fiber (Product number: 40300 Primary DI number: 4260649160275) - Trolley with power supply (Touch OrthoPhys -Trolley version (12000). This device is Laserneedle Touch Orthophys with 5 Red (5R) and 5 Infra red (5IR) lasers. Under the scope of delivery of the Laserneedle device package are included the following accessories / consumables / spare parts: - Regular optical fiber (Product number: 40200; Primary DI number: 4260649160244) - Quartz optical fiber (Product number: 40300 Primary DI number: 4260649160275) - Trolley with power supply (Product number: 35000 Primary DI number: 4260649160213) - Laser protection goggles (Product number: 32010 Primary DI number: 4260649160305) - LN Tape (Product number: 40100 Primary DI number: 4260649160466) - Self adhesive applicator (Product number: 40510 Primary DI number: 4260649160404) - LN Tip caps (Product number: 40710 Primary DI number: 4260649160503) - Set of silicon pads (Product number: 40600; Primary DI number: 4260649160312) - Silicone applicators (Product number: 40410; Primary DI number: 4260649160411) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260649160046 FDA UDI
- FDA Product Code
- ILY FDA UDI
- GMDN Term
- Musculoskeletal/physical therapy laser, professional FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5500 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Musculoskeletal/physical therapy laser, professional
Laserneedle Touch by Laserneedle GmbH — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Manufacturer's product page: Laserneedle Touch Orthophys
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Laserneedle GmbH
Sources (2)
- FDA UDI 48ede6ee-1ce7-4c43-a94f-d81903a47b01 33 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 3, 2026