FDA Recalls Photonica Light Modulator for Marketing Without Clearance
Advanced Photonic Systems is recalling 235 Photonica Light Modulator units because they were marketed without FDA clearance or approval.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II due to marketing without clearance, which falls under the rubric for minor labeling or regulatory errors without reported injuries.
Plain-English summary
Advanced Photonic Systems, LLC is recalling 235 units of the Photonica Light Modulator. The recall includes models ULT-1, TDR-1, and TDR-2, as well as products sold under various brand names such as UltraSlim, Luxurian, BioSlim Lipo, Cellulize, Slim 'n Trim, UltraRed, UltraBlue, Slim-PRO, Dazzle Light, UltraSlim Cold Light, SlenderRay, and U-Slim It.
The FDA has classified this as a Class II recall because the devices were marketed without the required marketing clearance or approval. The company claims the product provides non-invasive solutions to improve the appearance of fat accumulations, cellulite, fine lines, wrinkles, skin tone, and blemishes.
The affected units were distributed worldwide, including in 24 U.S. states and internationally to Canada, France, and Switzerland. Consumers who possess these devices should stop using them and contact the recalling firm for instructions on how to proceed.
The recalled product
- Product
- Photonica Light Modulator. 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. C
- Manufacturer
- Advanced Photonic Systems, LLC
- Hazard
- Affected units
- 235
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Models ULT-1
- TDR-1
- and TDR-2
Distribution
Part of a larger recall action
This product is one of 3 recalled by Advanced Photonic Systems, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
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