Aerolase Corporation
Tarrytown, NY, US
AEROLASE CORPORATION appears in FDA device records in Tarrytown, NY. FDA records list no 510(k) clearances, no PMA records and one registered establishment. As of , FDA records show 3 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3004374705 | 3004374705 | AEROLASE CORPORATION | 120 White Plains Road, Tarrytown, NY 10591 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0769-2020 | LightPod Neo Lasers | This relates to the standard 21 CFR 1040.10(f)(3) requiring a readily available remote interlock connector for the laser device | Class II | Terminated | |
| Z-0768-2020 | LightPod ERA lasers | This relates to the standard 21 CFR 1040.10(f)(3) requiring a readily available remote interlock connector for the laser device | Class II | Terminated | |
| Z-1188-2012 | 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. | It was discovered that customers were not supplied with a procedure and schedule for calibrating the FriendlyLight YAG lasers. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain