Data / Medical devices / United States / Photonica USA LLC

Photonica USA LLC: FDA-registered device maker in Cocoa Beach, FL, United States, 4 510(k) clearances

Name: Photonica USA LLC FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Photonica USA LLC is registered with the FDA (registration 3010053203) in Cocoa Beach, FL, United States. It lists 3 device types. The FDA files 4 510(k) clearances under its listings, the newest dated December 18, 2020. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3010053203
Address: 1980 N Atlantic Ave Ste 1008, Cocoa Beach, FL, United States, 32931
Owner or operator: Photonica USA LLC (10088608)
Roles: Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer
First device listed: August 29, 2023
Registered through: 2026
Brand names listed: Alesis OSA1, UltraSlim, UltraSlim Digital, UltraSlim Digital / UltraSlim Professional, UltraSmooth, UltraSmooth Digital, Vevazz ELITE

Devices it lists

Device	Product code	Class	Role	Source
Fat Reducing Low Level Laser	OLI	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Lamp, Infrared, Therapeutic Heating	ILY	2	Complaint file establishment, Repackager or relabeler, Specification developer	accessdata.fda.gov
Powered Laser Surgical Instrument	GEX	2	Complaint file establishment, Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
December 18, 2020	K202361	UltraSlim Digital, UltraSmooth Digital	OLI	Substantially Equivalent	Ward Photonics, LLC	accessdata.fda.gov
September 21, 2018	K180338	Cellulize	OLI	Substantially Equivalent	Ward Photonics, LLC	accessdata.fda.gov
September 23, 2016	K160880	Photonica Professional	OLI	Substantially Equivalent	Ward Photonics, LLC	accessdata.fda.gov
February 24, 2015	K150336	Photonica Professional	GEX	Substantially Equivalent	Ward Photonics, LLC	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
May 6, 2014	69117	Class II	Terminated	Ultraslim. 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	Marketing without marketing clearance or approval.	accessdata.fda.gov

Compare with other makers

Updated December 18, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.