Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2646-2014·Announced 2014-09-24

Advanced Photonic Systems Recalls Luxurian Devices for Marketing Violations

Advanced Photonic Systems is recalling 235 Luxurian devices because they were marketed without FDA clearance or approval.

The agency’s classification

FDA (Devices): Class II

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.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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, which typically corresponds to a moderate severity score when no specific physical injury or illness is reported, but rather a regulatory violation regarding marketing clearance.

Plain-English summary

Advanced Photonic Systems, LLC is recalling 235 units of the Luxurian device, including products labeled as UltraSlim, BioSlim Lipo, Cellulize, Slim 'n Trim, UltraRed, UltraBlue, Slim-PRO, Dazzle Light, UltraSlim Cold Light, SlenderRay, and U-Slim It. The company claims these products provide non-invasive solutions to improve the appearance of fat accumulations, cellulite, fine lines, wrinkles, skin tone, and blemishes.

The recall is due to marketing the devices without obtaining the required marketing clearance or approval from the FDA. The devices were distributed worldwide, including in the United States (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) and internationally to Canada, France, and Switzerland.

Consumers who purchased these devices should stop using them and contact Advanced Photonic Systems, LLC for further instructions.

The recalled product

Product: 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…
Manufacturer: Advanced Photonic Systems, LLC
Category: Medical Device — Aesthetic Devices
Hazard: regulatory-violation
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 (1)

Model 150

Distribution

Distributed in 24 states:

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 →

Same manufacturer · Advanced Photonic Systems, LLC

See all →

Moderate
FDA Recalls Photonica Light Modulator for Marketing Without Clearance
FDA (Devices) · 2014-09-24
Moderate
FDA Recalls Ultraslim Devices for Marketing Without Clearance
FDA (Devices) · 2014-09-24

Same hazard · regulatory violation