DentaLaze Kit

FDA UDI

Class II (US FDA UDI)

by Shofu Dental Corp.

Identity

Trade Name: DentaLaze Kit FDA UDI
Generic Name: General/multiple surgical diode laser system FDA UDI
Device Name: DentaLaze Diode Laser Kit with the following content: Laser Handpiece (Main Control & Battery), 2 goggles, 1 laser shield, 5 fiber tips, 50 laser sheaths, 1 charging stand, 1 power adapter, IFU, Box Oversleeve, Labels: box, fiber tips, charging stand, Danger sign FDA UDI
Model / Reference: DL001 FDA UDI
Description: DentaLaze Diode Laser Kit with the following content: Laser Handpiece (Main Control & Battery), 2 goggles, 1 laser shield, 5 fiber tips, 50 laser sheaths, 1 charging stand, 1 power adapter, IFU, Box Oversleeve, Labels: box, fiber tips, charging stand, Danger sign FDA UDI

Identifiers

Catalog Number: DL001 FDA UDI
Primary DI / UDI-DI: E235DL0010 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

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: General/multiple surgical diode laser system

DentaLaze Kit by Shofu Dental Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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:

Ultrafast Diode Laser — DENTLIGHT 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: Shofu Dental Corp.

Sources (1)

FDA UDI 900df90e-b156-4846-9ff8-eac8f15d3c1b 36 fields · synced Jun 8, 2026