RegWardenFDA facility compliance records
Facility

DermLite LLC

1 recall(s) on record — most severe on record: Class II.

Activity by year

FDA actions on record by year2023: 1 recalls20172018201920202021202212023202420252026
  • Recalls (1)

Devices registered here (1)

  • Light, Examination, Medical, Battery Powered
    Product code KYT (opens in a new tab) · Class I · General Hospital · 21 CFR 880.6350

Recalls & enforcement

  • Class IIOngoing2023-03-20
    Incorrect labeling; Package labeling contains a different serial number then the serial number on the product labeling.

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “DermLite LLC (FEI 3003452144) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3003452144-dermlite-llc/

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