Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2647-2014·Announced 2014-09-24

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.

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 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.…
Manufacturer: Advanced Photonic Systems, LLC
Category: Medical Device — Aesthetic Device
Hazard: mis-labeling
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

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
Advanced Photonic Systems Recalls Luxurian Devices for Marketing Violations
FDA (Devices) · 2014-09-24
Moderate
FDA Recalls Ultraslim Devices for Marketing Without Clearance
FDA (Devices) · 2014-09-24

Same hazard · mis labeling