FDA-Device2025-03-12Class II
(1) Lumenis Pulse 120H 30 amp, REF GA 2009996, Laser System; (2) Lumenis Pulse 120H, Moses 2.0 (DOM), REF GA0006802, Laser System; and (3) Lumenis Pulse 120H, REF GA-0008700, Laser System.
LUMENIS, LTD.
Hazard
The initial current in certain chargers may lead to overheating and damage to the power resistors on the Alternating Current (AC) controller during the power-on sequence of the laser system, resulting in the laser system to not power on.
Sold states
Distribution was made to PA. There was no government/military distribution. Foreign distribution was made to Mexico and Spain.
Affected count
3 devices
Manufactured in
Yokneam Ind. Park, 6, Ha-Kidma, Yokne'Am Ilit, Israel
Products
(1) Lumenis Pulse 120H 30 amp, REF GA 2009996, Laser System; (2) Lumenis Pulse 120H, Moses 2.0 (DOM), REF GA0006802, Laser System; and (3) Lumenis Pulse 120H, REF GA-0008700, Laser System.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1290-2025Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief