CLASS II Device recall · Reported 24 Sep 2014 · FDA Enforcement Report
Luxurian. These include all products labeled as UltraSlim recalled
Advanced Photonic Systems is recalling Luxurian. These include all products labeled as UltraSlim, Luxurian, BioSlim Lipo, distributed nationwide in the US. The recall was initiated on 6 May 2014 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-2646-2014
- FDA event ID
- 69117
- Recalling firm
- Advanced Photonic Systems, Cocoa Beach, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 May 2014
- FDA classified
- 16 Sep 2014
- Reported
- 24 Sep 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Masks, Gloves & PPE
Timeline
| 6 May 2014 | Recall initiated by company | |
| 16 Sep 2014 | Classified by FDA | +133 days |
| 24 Sep 2014 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Marketing without marketing clearance or approval.
Product as listed by the FDA
Luxurian. These include all products labeled as UltraSlim, Luxurian, BioSlim Lipo, Cellulize, Slim 'n Trim, UltraRed, UltraBlue, Slim-PRO, Dazzle Light, UltraSlim Cold Light, SlenderRay, and U-Slim It, as well as those products with private labelling branding. Company claims that the product provide non-invasive solutions to improve the appearance of fat accumulations, cellulite, fine lines, wrinkles, skin tone, and blemishes.
Where it was distributed
Worldwide Distribution - US- AL, AZ, CA, CO, FL, GA, ID, IL, IN, LA, MA, MD, MI, MN, MO, NV, NJ, NY, NC, OH, PA, TX, UT, and VA. Internationally to Canada, France, and Switzerland
Nationwide AlabamaArizonaCaliforniaColoradoFloridaGeorgiaIdahoIllinoisIndianaLouisianaMassachusettsMarylandMichiganMinnesotaMissouriNorth CarolinaNew JerseyNevadaNew YorkOhio
Questions about this recall
Is Luxurian. These include all products labeled as UltraSlim, Luxurian, BioSlim Lipo recalled?
Yes. Advanced Photonic Systems recalled Luxurian. These include all products labeled as UltraSlim, Luxurian, BioSlim Lipo on 6 May 2014. The recall is Class II and its status is Terminated. Recall number Z-2646-2014.
Why was it recalled?
Marketing without marketing clearance or approval.
Which lots are affected?
Model 150
Where was it sold?
Worldwide Distribution - US- AL, AZ, CA, CO, FL, GA, ID, IL, IN, LA, MA, MD, MI, MN, MO, NV, NJ, NY, NC, OH, PA, TX, UT, and VA. Internationally to Canada, France, and Switzerland
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 Advanced Photonic Systems
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Photonica Light Modulator recalled by Advanced Photonic Systems | Advanced Photonic Systems | Other | Nationwide |
| Device | CLASS II | Ultraslim. These include all products labeled as UltraSlim recalled | Advanced Photonic Systems | Other | Nationwide |
Other Masks, Gloves & PPE recalls
All 447| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | P28 Phanton Intramedullary Nail System recalled by Paragon 28 | Paragon 28 | Sterility | Nationwide |
| Device | CLASS II | Cyberknife Treatment Deliver System equipped recalled | Accuray Incorporated | Device Malfunction | Nationwide |
| Device | CLASS II | Adapter for Head Positioning recalled by Baxter Healthcare | Baxter Healthcare | Other | Nationwide |
| Device | CLASS II | Cyberknife Treatment Deliver System equipped recalled | Accuray Incorporated | Device Malfunction | Nationwide |
| Device | CLASS II | Halyard Purezero Ultraviolet Nitrile Exam Gloves Reference recalled | O&m Halyard | Other | Nationwide |