Identity
- Trade Name
- Gemini EVO FDA UDI
- Generic Name
- Dental diode laser system FDA UDI
- Device Name
- Refill accessory for Gemini EVO kit FDA UDI
- Model / Reference
- 9123 FDA UDI
- Description
- Refill accessory for Gemini EVO kit FDA UDI
Identifiers
- Catalog Number
- G2-5-007 FDA UDI
- Primary DI / UDI-DI
- 00850010501093 FDA UDI
- 510(k) Number
- K210350 FDA UDI
- FDA Product Code
- ILY FDA UDI
- GMDN Term
- Dental diode laser system 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dry Heat Sterilization FDA UDI
Category: Dental diode laser system
Gemini EVO by Azena Medical, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental diode laser system.
- NV®PRO3 — Den-Mat Holdings, LLC · Class II
- NV® — Den-Mat Holdings, LLC · Class II
- Dental Diode Laser System — Lazon Medical Laser Co., Ltd. · Class II
- STERLING® — Den-Mat Holdings, LLC · Class II
- SOL® — Den-Mat Holdings, LLC · Class II
- BLU — Peter Brasseler Holdings, LLC · Class II
- Pioneer Elite Perio Tip — CAO GROUP, INC. · Class II
- iLase Handpiece — Biolase, Inc. · Class II
Cleared under the same submission
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
- Azena Medical, LLC
Sources (1)
- FDA UDI 4593ac24-73c9-407c-a76f-e7bd2e7515c5 35 fields · synced May 29, 2026