11 results
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32ms
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Sources: EU EUDAMED, US FDA
Aerolase Corporation
Manufacturer
🇺🇸 United States
AEROLASE CORPORATION
FDA registration
AEROLASE CORPORATION·2 products·🇺🇸 United States
Aerolase
FDA UDI
AEROLASE CORPORATION·00863172000311·medical aesthetic laser for skin resurfacing
Aerolase
FDA UDI
AEROLASE CORPORATION·00863172000304·Medical aesthetic laser
Aerolase
FDA UDI
AEROLASE CORPORATION·08631720003020·Medical Aesthetic Laser for skin resurfacing
Aerolase Corporation. The products involved are the FriendlyLight YAG lasers, a Model Family first identified and reported. The products are marketed under names including FriendlyLight Er:YAG, LightPod Era, FriendlyLight Nd:YAG, LightPod Neo, LightPod Neo XL, LightPod Neo XT, LightPod Forte, LightPod Allure, and LightPod Nova.
FDA Recall
Terminated
·Aerolase·Product code GEX·June 7, 2011
LightPod Neo Lasers
FDA Recall
Terminated
·Aerolase Corporation·Product code GEX·August 1, 2019
LightPod ERA lasers
FDA Recall
Terminated
·Aerolase Corporation·Product code GEX·August 1, 2019
LightPod ERA lasers
FDA Enforcement
Class II
·Terminated·Aerolase Corporation·January 15, 2020
LightPod Neo Lasers
FDA Enforcement
Class II
·Terminated·Aerolase Corporation·January 15, 2020
MDSS GmbH
Authorized representative
🇩🇪 Germany·388 Manufacturers·16562 Devices