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Doctor Smile / Doctor Diode Laser

FDA UDI

Class I (US FDA UDI)

by Lambda Spa

Identity

Trade Name
Doctor Smile / Doctor Diode Laser FDA UDI
Generic Name
Laser beam eye protector, patient FDA UDI
Device Name
Eye protection (LOEYW002.0) against laser light at 980 nm FDA UDI
Model / Reference
Protective eye wear FDA UDI
Description
Eye protection (LOEYW002.0) against laser light at 980 nm FDA UDI

Identifiers

Catalog Number
LOEYW002.0 FDA UDI
Primary DI / UDI-DI
08056093611090 FDA UDI
510(k) Number
K091562 FDA UDI
K102036 FDA UDI
FDA Product Code
HOY FDA UDI
GMDN Term
Laser beam eye protector, patient FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
886.4750 FDA UDI
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

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Laser beam eye protector, patientLaser beam eye protector, staff

Doctor Smile / Doctor Diode Laser by Lambda Spa — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Laser beam eye protector, staff.

Cleared under the same submission

K091562 also covers:

K102036 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Lambda Spa

Sources (1)

  • FDA UDI fb6047db-df1e-48f3-b420-5fb1178b6029 35 fields · synced May 30, 2026