Ultrafast Diode Laser

FDA UDI

Class II (US FDA UDI)

by Dentlight Inc.

Identity

Trade Name: Ultrafast Diode Laser FDA UDI
Generic Name: General/multiple surgical diode laser system FDA UDI
Device Name: Ultrafast Diode Laser FDA UDI
Model / Reference: 7300100 FDA UDI
Description: Ultrafast Diode Laser FDA UDI

Identifiers

Catalog Number: 7300100 FDA UDI
Primary DI / UDI-DI: 00860179001044 FDA UDI
510(k) Number: K201387 FDA UDI
FDA Product Code: NVK FDA UDI
GMDN Term: General/multiple surgical 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

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

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

Yes

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: General/multiple surgical diode laser system

Ultrafast Diode Laser by Dentlight Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as General/multiple surgical diode laser system.

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Assy Final HS SLA IQ532 Standard Mount — Iridex Corporation · Class II
Visualase — MEDTRONIC NAVIGATION, INC. · Class I
GIGAA — Wuhan Gigaa Optronics Technology Co., Ltd. · Class II
Epic S-Series Diode Laser System — Biolase, Inc. · Class II

Cleared under the same submission

K201387 also covers:

DentaLaze Kit — SHOFU DENTAL CORP.

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: Dentlight Inc.

Sources (1)

FDA UDI 99c39b2d-791b-4f78-9f1b-d16f2d3becdc 35 fields · synced May 30, 2026