LightPod ERA lasers — Class II medical device recall Z-0768-2020
Terminated recall by Aerolase Corporation, reported 2020-01-15, distributed nationwide. This relates to the standard 21 CFR 1040.10(f)(3) requiring a readily available remote interlock connector for
| Recall number | Z-0768-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Aerolase Corporation, Tarrytown, NY, United States |
| Recall initiated | 2019-08-01 |
| Classified | 2020-01-03 |
| Reported by FDA | 2020-01-15 |
| Terminated | 2021-03-30 |
| Distributed | Nationwide (US) |
| Quantity | 65 |
Product
LightPod ERA lasers
Reason for recall
This relates to the standard 21 CFR 1040.10(f)(3) requiring a readily available remote interlock connector for the laser device
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0768-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.