Data / Medical devices / United States / The Lotus Global Group, Inc.
The Lotus Global Group, Inc.: FDA-registered device maker in Napa, CA, United States, 5 510(k) clearances
The Lotus Global Group, Inc. is registered with the FDA (registration 3008776882) in Napa, CA, United States. It lists 2 device types. The FDA files 5 510(k) clearances under its listings, the newest dated August 9, 2005. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3008776882
- Address
- 1290 Jefferson St Ste C, Napa, CA, United States, 94559
- Owner or operator
- GlobalMed Technologies Co (10051883)
- Roles
- Specification developer
- First device listed
- May 16, 2016
- Registered through
- 2027
- Brand names listed
- Omnilux Blue, Omnilux Plus, Omnilux Revive, Omnilux Revive & Blue, Omnilux Revive & Plus
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Lamp, Infrared, Therapeutic Heating | ILY | 2 | Specification developer | accessdata.fda.gov |
| Powered Laser Surgical Instrument | GEX | 2 | Specification developer | 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 |
|---|---|---|---|---|---|---|
| August 9, 2005 | K050216 | OMNILUX REVIVE AND OMNILUX PLUS | GEX | Substantially Equivalent | Photo Therapeutics Limited | accessdata.fda.gov |
| March 18, 2005 | K043329 | OMNILUX REVIVE AND BLUE | GEX | Substantially Equivalent | Photo Therapeutics Limited | accessdata.fda.gov |
| March 15, 2005 | K043317 | OMNILUX PLUS | ILY | Substantially Equivalent | Photo Therapeutics Limited | accessdata.fda.gov |
| July 17, 2003 | K030426 | OMNILUX RED | GEX | Substantially Equivalent | Photo Therapeutics Limited | accessdata.fda.gov |
| June 18, 2003 | K030883 | OMNILUX BLUE | GEX | Substantially Equivalent | Photo Therapeutics Limited | accessdata.fda.gov |
Compare with other makers
Updated August 9, 2005. 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.