Identity
- Trade Name
- MultiPulse Ho FDA UDI
- Generic Name
- General/multiple surgical solid-state laser system FDA UDI
- Device Name
- The device includes a Ho:Yag laser source with 35W max output power at 2100 nm wavelength. The optical delivery system is an optical fiber. FDA UDI
- Model / Reference
- J19-1310-000 FDA UDI
- Description
- The device includes a Ho:Yag laser source with 35W max output power at 2100 nm wavelength. The optical delivery system is an optical fiber. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04058784001092 FDA UDI
- 510(k) Number
- K163449 FDA UDI
- FDA Product Code
- GEX FDA UDI
- GMDN Term
- General/multiple surgical solid-state laser system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4810 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
Yes
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: General/multiple surgical solid-state laser system
MultiPulse Ho by Asclepion Laser Technologies GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as General/multiple surgical solid-state laser system.
- O35 — HYPER PHOTONICS SRL · Class II
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- LOTUS Ⅱ power cable — Laseroptek Co., Ltd · Class II
- DEKA LIPOAI — EL.EN. SPA · Class II
- SOLTIVE — Gyrus Acmi, Inc. · Class II
- Thuvera — IPG Medical Corporation · Class II
- ACCENTO — Bison Medical Co, Ltd. · Class II
Cleared under the same submission
K163449 also covers:
- HYPHO — HYPER PHOTONICS SRL
- O35 — HYPER PHOTONICS SRL
- Re-Usable surgical optical fiber — HYPER PHOTONICS SRL
- Re-Usable surgical optical fiber — HYPER PHOTONICS SRL
- Re-Usable surgical optical fiber — HYPER PHOTONICS SRL
- Re-Usable surgical optical fiber — HYPER PHOTONICS SRL
- Single use surgical optical fiber — HYPER PHOTONICS SRL
- Single use surgical optical fiber — HYPER PHOTONICS SRL
- Single use surgical optical fiber — HYPER PHOTONICS SRL
- Single use surgical optical fiber — HYPER PHOTONICS SRL
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Asclepion Laser Technologies GmbH
Sources (1)
- FDA UDI f825a40d-2e58-48b5-b429-e084c81bfce9 35 fields · synced May 30, 2026