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G.o.c.c.l.e.s. light

FDA UDI

Class II (US FDA UDI)

by Pierrel Spa

Identity

Trade Name
G.o.c.c.l.e.s. light FDA UDI
Generic Name
Oral lesion examination light FDA UDI
Device Name
G.o.c.c.l.e.s light represents the proprietary light source to be used with G.o.c.c.l.e.s eyewear in order to allow the illumination of the oral cavity during oral examination, characterized by an excitation band from 440 to 490 nm. FDA UDI
Model / Reference
G.o.c.c.l.e.s. light FDA UDI
Description
G.o.c.c.l.e.s light represents the proprietary light source to be used with G.o.c.c.l.e.s eyewear in order to allow the illumination of the oral cavity during oral examination, characterized by an excitation band from 440 to 490 nm. FDA UDI

Identifiers

Catalog Number
531000611 FDA UDI
Primary DI / UDI-DI
08051040582010 FDA UDI
510(k) Number
K151630 FDA UDI
FDA Product Code
NXV FDA UDI
GMDN Term
Oral lesion examination light FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.6350 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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Oral lesion examination light

G.o.c.c.l.e.s. light by Pierrel Spa — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Oral lesion examination light.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Pierrel Spa

Sources (1)

  • FDA UDI f16c7131-2782-40d3-b6ed-fc65e3a5f587 37 fields · synced Jun 6, 2026