Doctor Smile

FDA UDI

Class II (US FDA UDI)

by Lambda Spa

Identity

Trade Name: Doctor Smile FDA UDI
Generic Name: General/multiple surgical diode laser system FDA UDI
Device Name: Doctor Smile B-980 Laser (Doctor Smile D5 980 nm) is a standard diode medical laser with 980 nm wavelength. It is intended for use in the following procedure: surgical applications requiring the ablation, vaporization, excision, incision, haemostasis, or coagulation of soft tissue in medical specialties including dentistry, dermatology, general surgery, gynecology, opthamology, pulmonology, otolaryngology, othopedics. FDA UDI
Model / Reference: Doctor Smile B-980 FDA UDI
Description: Doctor Smile B-980 Laser (Doctor Smile D5 980 nm) is a standard diode medical laser with 980 nm wavelength. It is intended for use in the following procedure: surgical applications requiring the ablation, vaporization, excision, incision, haemostasis, or coagulation of soft tissue in medical specialties including dentistry, dermatology, general surgery, gynecology, opthamology, pulmonology, otolaryngology, othopedics. FDA UDI

Identifiers

Primary DI / UDI-DI: 08056093610062 FDA UDI
510(k) Number: K091562 FDA UDI
FDA Product Code: GEX 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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: General/multiple surgical diode laser system

Doctor Smile by Lambda Spa — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K091562 also covers:

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: Lambda Spa

Sources (1)

FDA UDI 8b30d215-28fe-405f-b92a-13c6f5044236 34 fields · synced May 31, 2026