Identity
- Trade Name
- Novilase Laser Therapy Pack FDA UDI
- Generic Name
- General/multiple surgical laser system beam guide, single-use FDA UDI
- Device Name
- Procedure pack for Novilase Laser Therapy System containing single-use disposables for laser ablation procedure. Pack contains sterile kit with (1) 110 mm laser probe with removable stylet and 1 temperature sensor, (1) 110 mm thermal probe with 5 temperature sensors, (1) optical fiber, and (1) probe guide; and (1) 30 ml sterile syringe. For distribution in USA/EU/UK. FDA UDI
- Model / Reference
- USA/EU/UK: 110 mm FDA UDI
- Description
- Procedure pack for Novilase Laser Therapy System containing single-use disposables for laser ablation procedure. Pack contains sterile kit with (1) 110 mm laser probe with removable stylet and 1 temperature sensor, (1) 110 mm thermal probe with 5 temperature sensors, (1) optical fiber, and (1) probe guide; and (1) 30 ml sterile syringe. For distribution in USA/EU/UK. FDA UDI
Identifiers
- Catalog Number
- 100011-02 FDA UDI
- Primary DI / UDI-DI
- 00860008944801 FDA UDI
- GMDN Term
- General/multiple surgical laser system beam guide, single-use FDA UDI
Classification
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: General/multiple surgical laser system beam guide, single-use
Novilase Laser Therapy Pack by Novian Health Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as General/multiple surgical laser system beam guide, single-use.
- Moses™ — Lumenis · Class II
- Flexiva Pulse — Boston Scientific · Class II
- InnoVoyce Laser Fiber — InnoVoyce LLC · Class II
- Trimedyne® OmniTip™ - 30 cm Side Firing Switchable Tip with Suction/Irrigation — TRIMEDYNE, INC. · Class II
- SlimLine™ 200 D/F/L LP — Lumenis · Class II
- Dornier MedTech — Dornier MedTech GmbH · Class II
- Olympus — Gyrus Acmi, Inc. · Class II
- Dornier MedTech — Dornier MedTech America, Inc. · Class II
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 | N/A | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Novian Health Inc.
Sources (1)
- FDA UDI ab153fb4-af2b-4afd-b454-f144c386176d 35 fields · synced Jun 9, 2026