810nm 1W Cluster (5x200mW) 2.0Recalls & reported problems
Thor Photomedicine Limited · S1160 810nm 1W Cluster (5x200mW) · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05060494130145), received between Mar 15, 2024 and Mar 15, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Excessive Heating” (3 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Excessive Heating3
Patient problems
- Burning Sensation3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 15, 2024Excessive Heating; Excessive Heating
ONE PROBE GETS TOO HOT FOR COMFORT AFTER ABOUT 10 MINUTES OF USE, THE OTHER PROBE DOES NOT GET UNCOMFORTABLY HOT AT ALL, NO MATTER HOW LONG IT IS USED.
Patient problems: Burning Sensation
MAUDE report 18918777 ↗MalfunctionMar 15, 2024Excessive Heating; Excessive Heating
OLD DD2 MACHINE, THE LASER CLUSTER PROBE IS GETTING EXTREMELY HOT AROUND THE WHOLE OF THE LASER HEAD
Patient problems: Burning Sensation
MAUDE report 18918776 ↗MalfunctionMar 15, 2024Excessive Heating; Excessive Heating
810NM 1W CLUSTER PROBE HEATS UP TO THE POINT IT IS UNCOMFORTABLE TO LEAVE IT ON THE SKIN WHEN TREATING.
Patient problems: Burning Sensation
MAUDE report 18918774 ↗
Other Lamp, Infrared, Therapeutic Heating devices
- NovoTHOR 3.0Thor Photomedicine Limited · Lamp, Infrared, Therapeutic Heating2 recalls0 reports
- NovoTHOR XL 3.0Thor Photomedicine Limited · Lamp, Infrared, Therapeutic Heating2 recalls0 reports
- NovoTHOR PRX 3.0Thor Photomedicine Limited · Lamp, Infrared, Therapeutic Heating1 recall0 reports
- NovoTHOR Gen 3.0 Reg PRXThor Photomedicine Limited · Lamp, Infrared, Therapeutic Heating1 recall0 reports
- CHATTANOOGA 27812Djo, LLC · Lamp, infrared, therapeutic heating3 reports
- CHATTANOOGA 27840Djo, LLC · Lamp, infrared, therapeutic heating2 reports
- LightForce FXi LTC-1500Litecure LLC · Lamp, Infrared, Therapeutic Heating1 report
- 810nm 16W Cluster PRX100 (80x200mW) 2.3Thor Photomedicine Limited · Lamp, Infrared, Therapeutic Heating1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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