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Dental Diode Laser System

FDA 510(k)FDA UDI

Class II (US FDA 510(k))

510(k) K180967

by Lazon Medical Laser Co., Ltd.

Identity

Trade Name
Dental Diode Laser System FDA UDI
Generic Name
Dental diode laser system FDA UDI
Model / Reference
SOLASE-808 FDA UDI

Identifiers

Catalog Number
04 FDA UDI
Primary DI / UDI-DI
06970750060040 FDA UDI
510(k) Number
K180967 FDA 510(k)FDA UDI
FDA Product Code
GEX FDA 510(k)FDA UDI
GMDN Term
Dental diode laser system FDA UDI

Classification

Device Class
Class II FDA 510(k)FDA UDI
Legislation / Framework
21 CFR Part 878.4810 FDA 510(k)
Regulation Number
878.4810 FDA 510(k)FDA UDI
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)
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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Dental Diode Laser System by Lazon Medical Laser Co., Ltd. — Class II — FDA_510K — listed in FDA 510(k), FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Lazon Medical Laser Co., Ltd.

Sources (2)

  • FDA 510(k) K180967 24 fields · synced Jun 18, 2026
  • FDA UDI 87aa1e23-dbbc-487a-a300-8d7a76a502f3 34 fields · synced May 27, 2026