Identity
- Trade Name
- KLARO In Vivo Surgical Lighting FDA UDI
- Generic Name
- Open surgical site internal light FDA UDI
- Device Name
- KLARO is a deep-cavity surgical LED lighting device for open surgery use. It is discreet, easy to use and provides bright, uniform and localised "flood-lighting" from within the surgical site. KLARO maintains a safe and cool working temperature suited for use inside the human body regardless of the luminous intensity selected. FDA UDI
- Model / Reference
- 555-01-01 FDA UDI
- Description
- KLARO is a deep-cavity surgical LED lighting device for open surgery use. It is discreet, easy to use and provides bright, uniform and localised "flood-lighting" from within the surgical site. KLARO maintains a safe and cool working temperature suited for use inside the human body regardless of the luminous intensity selected. FDA UDI
Identifiers
- Catalog Number
- 555-01-01 FDA UDI
- Primary DI / UDI-DI
- 08881300212001 FDA UDI
- FDA Product Code
- FTD FDA UDI
- GMDN Term
- Open surgical site internal light FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4580 FDA UDI
- 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Open surgical site internal light
KLARO In Vivo Surgical Lighting by Vivo Surgical Private Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Open surgical site internal light.
- Thompson Surgical Instruments Lite Path Integrated Double 13mm — LUMITEX, INC. · Class I
- BOSS Instruments — Boss Instruments, Ltd. · Class I
- Bones and Nerves Disposable Single Leg Surgical Illuminator — LUMITEX, INC. · Class I
- 4WEB Medical OA51S Surgical Illuminator — LUMITEX, INC. · Class I
- DePuy TSS Retractor Light Strip 5-Pack — LUMITEX, INC. · Class I
- Sunoptic Technologies — Sunoptic Technologies · Class II
- EMSRUN — Wuxi Emsrun Technology Co., Ltd. · Class I
- NICO Myriad — NICO Corporation · 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 | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Vivo Surgical Private Limited
Sources (1)
- FDA UDI 67aff76c-1ccd-4a78-92f4-c7cd35ae415b 36 fields · synced Jun 6, 2026