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Gemini EVO

FDA UDI

Class II (US FDA UDI)

by Azena Medical, LLC

Identity

Trade Name
Gemini EVO FDA UDI
Generic Name
Dental diode laser system FDA UDI
Device Name
Refill/accessory for power supply for Gemini EVO FDA UDI
Model / Reference
9125 FDA UDI
Description
Refill/accessory for power supply for Gemini EVO FDA UDI

Identifiers

Catalog Number
G2-5-004 FDA UDI
Primary DI / UDI-DI
00850010501116 FDA UDI
510(k) Number
K210350 FDA UDI
FDA Product Code
NVK FDA UDI
GEX FDA UDI
ILY FDA UDI
GMDN Term
Dental diode laser system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4810 FDA UDI
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

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.

Cleared under the same submission

K210350 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Azena Medical, LLC

Sources (1)

  • FDA UDI 23a12ed4-18dc-4dd4-8729-add780d00b3b 35 fields · synced Jun 6, 2026