Device recall: LightPod ERA lasers
Aerolase Corporation (Tarrytown, NY) initiated this device recall on 1 Aug 2019; FDA lists 2 product records under event 84568, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 88% of the 968 device enforcement events initiated in 2019 carry the same class.
Status: Terminated, terminated 30 Mar 2021. Initiation: voluntary: firm initiated. This is the only enforcement event on this register for Aerolase Corporation.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Aerolase Corporation, Tarrytown, NY.
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"
Distribution
"US Nationwide Distribution"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0768-2020 | LightPod ERA lasers | 65 | Class II | Terminated | 15 Jan 2020 |
| Z-0769-2020 | LightPod Neo Lasers | 649 | Class II | Terminated | 15 Jan 2020 |
Context
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "This relates to the standard 21 CFR 1040.10(f)(3) requiring a readily available remote interlock connector for the laser device"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US Nationwide Distribution"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 30 Mar 2021. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.