Zolar

FDA UDI

Class II (US FDA UDI)

by Zolar Technology & Mfg Co., Inc.

Identity

Trade Name: Zolar FDA UDI
Generic Name: Dental diode laser system FDA UDI
Model / Reference: Photon Plus FDA UDI

Identifiers

Primary DI / UDI-DI: 00628055817017 FDA UDI
510(k) Number: K122020 FDA UDI
FDA Product Code: GEX FDA UDI
GMDN Term: Dental diode 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

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Dental diode laser system

Zolar by Zolar Technology & Mfg Co., Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Dental diode laser system.

NV®PRO3 — Den-Mat Holdings, LLC · Class II
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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

K122020 also covers:

Zolar — Zolar Technology & Mfg Co., Inc.

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: Zolar Technology & Mfg Co., Inc.

Sources (1)

FDA UDI 9a543e3a-9d19-4d30-85cb-40dc1f364cc9 33 fields · synced Jun 8, 2026