Data / Medical devices / United Kingdom / THOR Photomedicine Ltd
THOR Photomedicine Ltd: FDA-registered device maker in Amersham Buckinghamshire, United Kingdom, 1 510(k) clearance
THOR Photomedicine Ltd is registered with the FDA (registration 3003899624) in Amersham Buckinghamshire, United Kingdom. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated March 17, 2004. 3 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3003899624
- Address
- Units 1 & 2 Anglo Office Park White Lion Road, Amersham Buckinghamshire, United Kingdom, HP7 9FB
- Owner or operator
- THOR Photomedicine Ltd (9054807)
- Roles
- Manufacturer, Specification developer
- First device listed
- February 5, 2008
- Registered through
- 2026
- Brand names listed
- LED Midi, LX2.3, LX2.3 Laser & LED Therapy System, Laser Max, Laser Max Package, Laser Max System, Laser Midi, Laser Pro and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Lamp, Infrared, Therapeutic Heating | ILY | 2 | Manufacturer, 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 |
|---|---|---|---|---|---|---|
| March 17, 2004 | K033923 | TH0R DDII IR LAMP SYSTEM | ILY | Substantially Equivalent | Thor Intl. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| July 24, 2025 | 97297 | Class II | Ongoing | Brand Name: THOR Product Name: NovoTHOR Model/Catalog Number: S2188 Software Version: N/A Product Description: The NovoTHOR and NovoTHOR XL are intended to emit energy in the visible and IR spectrum to provide topical he | The potential for a failed welded nut to shear off. When this occurs, the gas strut on one side of the device becomes detached from the canopy, making the canopy difficult to lift. | accessdata.fda.gov |
| November 20, 2023 | 93723 | Class II | Ongoing | NovoTHOR Whole Body Light Pod, Gen 3.0 (1) Product Code S2188 - Reg (2) Product Code S2189 - Reg PRX (3) Product Code S2190 - XL | One of the ball studs attaching a gas strut to the canopy may fail. There is potential risk of injury should a ball stud fail when someone is in the NovoTHOR and trying to open or close the canopy | accessdata.fda.gov |
| September 13, 2022 | 93344 | Class II | Ongoing | NovoTHOR Gen 2.0 whole body red light therapy bed, model S1176 | Failure of ball stud components causing the gas strut on one side to detach from the canopy, making the canopy difficult to lift. | accessdata.fda.gov |
Compare with other makers
Updated August 22, 2025. 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.