CLASS II Device recall · Reported 15 Jan 2020 · FDA Enforcement Report
LightPod Neo Lasers recalled by Aerolase
Aerolase is recalling LightPod Neo Lasers, distributed nationwide in the US. The recall was initiated on 1 Aug 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0769-2020
- FDA event ID
- 84568
- Recalling firm
- Aerolase, Tarrytown, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 1 Aug 2019
- FDA classified
- 3 Jan 2020
- Reported
- 15 Jan 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 1 Aug 2019 | Recall initiated by company | |
| 3 Jan 2020 | Classified by FDA | +155 days |
| 15 Jan 2020 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Product as listed by the FDA
LightPod Neo Lasers
Where it was distributed
US Nationwide Distribution
Questions about this recall
Is LightPod Neo Lasers recalled?
Yes. Aerolase recalled LightPod Neo Lasers on 1 Aug 2019. The recall is Class II and its status is Terminated. Recall number Z-0769-2020.
Why was it recalled?
This relates to the standard 21 CFR 1040.10(f)(3) requiring a readily available remote interlock connector for the laser device
Which lots are affected?
LightPod Neo Lasers
Where was it sold?
US Nationwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Aerolase
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | LightPod ERA lasers recalled by Aerolase | Aerolase | Other | Nationwide |
Other Other Medical Devices recalls
All 13,778| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Citric Complete Dry Citric Acid Concentrate recalled | Nipro Renal Soultions USA | Other | Nationwide |
| Device | CLASS I | Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | Halyard IV Start Kit Non-Sterile recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |