Device recall

Z-0095-2024: MED-810A Zemits NDPrime Laser products

FDA device recall · Class II · Advance-Esthetic LLC

Key facts

Recall number (Z-number) Z-0095-2024
Recall event 93194
Product MED-810A Zemits NDPrime Laser products
Product code GEX
Recalling firm Advance-Esthetic LLC
Recall class Class II
Status Open, Classified
FEI number 3013397886

At a glance

  • None Linked 510(k)s
  • 1–9 Products in the same recall event
  • 100–999 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

Browse all FDA device recalls (products)