Doctor Smile

FDA UDI

Class II (US FDA UDI)

by Lambda Spa

Identity

Trade Name: Doctor Smile FDA UDI
Generic Name: Dental diode laser system FDA UDI
Device Name: Doctor Smile Wiser 2 laser is a standard diode medical laser with 980 nm walelength. It is intended for use in the following procedure: Soft Tissue, Laser Periodontal procedures and tooth whitening, Intra and extra oral surgery incision, excision, vaporization, ablation, haemostasis and coagulation of oral soft tissues, Laser soft tissue curettage, whitening. The laser kit includes a wireless foot switch, the power supply, CD-ROM instruction (user manual, clinical protocols) and following items: 08056093610116 - Doctor smile wiser 2 08056093611106 and 08056093611090 - protective glasses 08056093611007 - Wiser tip endodontics 08056093611014 - Wiser tip periodontics 08056093611021 - Wiser tip surgery 08056093611038 - Wiser tip implant FDA UDI
Model / Reference: DOCTOR SMILE WISER 2 FDA UDI
Description: Doctor Smile Wiser 2 laser is a standard diode medical laser with 980 nm walelength. It is intended for use in the following procedure: Soft Tissue, Laser Periodontal procedures and tooth whitening, Intra and extra oral surgery incision, excision, vaporization, ablation, haemostasis and coagulation of oral soft tissues, Laser soft tissue curettage, whitening. The laser kit includes a wireless foot switch, the power supply, CD-ROM instruction (user manual, clinical protocols) and following items: 08056093610116 - Doctor smile wiser 2 08056093611106 and 08056093611090 - protective glasses 08056093611007 - Wiser tip endodontics 08056093611014 - Wiser tip periodontics 08056093611021 - Wiser tip surgery 08056093611038 - Wiser tip implant FDA UDI

Identifiers

Catalog Number: LA8D0001.3 FDA UDI
Primary DI / UDI-DI: 08056093610284 FDA UDI
510(k) Number: K102036 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

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

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: Dental diode laser system

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

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Also classified as Dental diode laser system.

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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

K102036 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 38fb9f44-55d8-4eba-bf2e-ee400f5a2491 35 fields · synced Jun 8, 2026