Data / Medical devices / United States / Aerolase Corporation
Aerolase Corporation: FDA-registered device maker in Tarrytown, NY, United States, 3 510(k) clearances
Aerolase Corporation is registered with the FDA (registration 3004374705) in Tarrytown, NY, United States. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated December 11, 2019. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004374705
- Address
- 120 White Plains Road SUITE 515, Tarrytown, NY, United States, 10591
- Owner or operator
- AEROLASE CORPORATION (9047647)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- August 27, 2021
- Registered through
- 2026
- Brand names listed
- Era Elite, Exci308, LightPod Era, LightPod Neo, Neo Elite
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Light, Ultraviolet, Dermatological | FTC | 2 | Repackager or relabeler | accessdata.fda.gov |
| Powered Laser Surgical Instrument | GEX | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 11, 2019 | K191086 | Exciplex | FTC | Substantially Equivalent | Clarteis | accessdata.fda.gov |
| September 17, 2012 | K120235 | MODEL FAMILY OF AEROLASE ND:YAG LASERS: FRIENDLYLIGHT ND: YAG LASERS, FRIENDLYLIGHT NEO, LIGHTPOD ND: YAG LASERS, LIGHTP | GEX | Substantially Equivalent | Aerolase Medical Lasers, LLC | accessdata.fda.gov |
| November 6, 2000 | K000023 | FRIENDLY LIGHT ER:YAG PULSED LASER | GEX | Substantially Equivalent | Innotech USA, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| August 1, 2019 | 84568 | Class II | Terminated | 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 | accessdata.fda.gov |
| June 7, 2011 | 61194 | Not yet classified | Terminated | 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, FriendlyLigh | It was discovered that customers were not supplied with a procedure and schedule for calibrating the FriendlyLight YAG lasers. | accessdata.fda.gov |
Compare with other makers
Updated December 11, 2019. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.