FDA Medical Device Recalls (openFDA)
Aerolase Corporation: LightPod ERA lasers
- Recall number
- Z-0768-2020
- Recalling firm
- Aerolase Corporation
- Product
- LightPod ERA lasers
- Status
- Terminated
- Initiated
- 2019-08-01
- Posted
- not on file
- Terminated
- 2021-03-30
- Reason
- This relates to the standard 21 CFR 1040.10(f)(3) requiring a readily available remote interlock connector for the laser device
- Root cause
- not on file
- Action
- Aerolase notified all customers to whom such product was delivered. Customer will be informed that the firm plan to provide immediately, and without charge, a remote interlock connector for use with their Aerolase lasers. For questions contact Aerolase in Tarrytown, NY at information@aerolase.com or 914-345-8300.
- Quantity
- 65
- Distribution
- US Nationwide Distribution
- Lot, serial or model codes
- LightPod ERA Lasers
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GEX
- Firm FEI
- 3004374705
- Firm city
- Tarrytown
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28