Identity
- Trade Name
- MultiPulse TM+1470 FDA UDI
- Generic Name
- General/multiple surgical solid-state laser system FDA UDI
- Device Name
- Surgical laser with 2 laser modules of 1940 nm and 1470 nm (both near infrared). Intended for surgical procedures using open, laparoscopic and endoscopic procedures of soft tissue in many medical specialties. FDA UDI
- Model / Reference
- 1901 FDA UDI
- Description
- Surgical laser with 2 laser modules of 1940 nm and 1470 nm (both near infrared). Intended for surgical procedures using open, laparoscopic and endoscopic procedures of soft tissue in many medical specialties. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04058784000118 FDA UDI
- 510(k) Number
- K133891 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 TM+1470 by Asclepion Laser Technologies GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K133891 also covers:
- Bare Fiber IR-Q 1000 — Asclepion Laser Technologies GmbH
- Bare Fiber IR-Q 200 — Asclepion Laser Technologies GmbH
- Bare Fiber IR-Q 400 — Asclepion Laser Technologies GmbH
- Bare Fiber IR-Q 600 — Asclepion Laser Technologies GmbH
- Bare Fiber IR-Q 800 — Asclepion Laser Technologies GmbH
- Bare Fiber R IR-Q 1000 — Asclepion Laser Technologies GmbH
- Bare Fiber R IR-Q 200 — Asclepion Laser Technologies GmbH
- Bare Fiber R IR-Q 400 — Asclepion Laser Technologies GmbH
- Bare Fiber R IR-Q 600 — Asclepion Laser Technologies GmbH
- Bare Fiber R IR-Q 800 — Asclepion Laser Technologies GmbH
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 468305ed-979f-4a42-ae09-300351701101 35 fields · synced May 30, 2026