FDA Device Intelligence
HomeDermLite LLC › DermLite Carbon

DermLite Carbon

DermLite LLC · Model DLC · UDI-DI 00855997006319

KYT
6
510(k) clearances
10
Adverse events
1
Recalls
159
Facilities

Description

Handheld dermatoscope (battery-operated, polarized, non-polarized, snap-on spacer)

Recalls

DateFirmReason
2023-03-20DermLite LLCIncorrect labeling; Package labeling contains a different serial number then the serial number on the product labeling.

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.