← Back to catalogue

DermLite DL1

FDA UDI

Class I (US FDA UDI)

by DermLite LLC

Identity

Trade Name
DermLite DL1 FDA UDI
Generic Name
Dermatoscope, optical FDA UDI
Device Name
Smartphone dermatoscope (rechargeable, includes polarized spacer & non-polarized spacer) FDA UDI
Model / Reference
DL1 FDA UDI
Description
Smartphone dermatoscope (rechargeable, includes polarized spacer & non-polarized spacer) FDA UDI

Identifiers

Catalog Number
DL1 FDA UDI
Primary DI / UDI-DI
00855997006036 FDA UDI
FDA Product Code
KYT FDA UDI
GMDN Term
Dermatoscope, optical FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
880.6350 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

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Dermatoscope, optical

DermLite DL1 by DermLite LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dermatoscope, optical.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
DermLite LLC

Sources (1)

  • FDA UDI e8f8301f-6ec7-4b06-9e9d-83113ce2a935 35 fields · synced Jun 7, 2026