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Sign in to claim this brandBiocare Systems, Inc.
US
Last updated May 31, 2026
What Biocare Systems, Inc. makes
Biocare Systems, Inc. manufactures non-wearable infrared phototherapy units designed for musculoskeletal applications. Their portfolio includes devices like the LUMIWAVE series and the PREMIR 818, which deliver targeted infrared therapy for therapeutic purposes.
These devices are classified as Class II under FDA regulations and are listed in the FDA’s 510(k) and UDI registries. The company is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Biocare Systems, Inc. manufacture?
Biocare Systems, Inc. specializes in non-wearable infrared phototherapy units. These devices are primarily designed for musculoskeletal applications, such as targeted infrared therapy to support therapeutic treatments. Examples include the LUMIWAVE series and the PREMIR 818, which are tailored for delivering controlled infrared light to affected areas.
Where is Biocare Systems, Inc. based?
Biocare Systems, Inc. is headquartered in the United States. The company’s location is relevant for understanding its regulatory framework and compliance with U.S. medical device standards.
In which regulatory registries are Biocare Systems, Inc.’s devices listed?
Biocare Systems, Inc.’s devices are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) registries. The 510(k) process is used to demonstrate substantial equivalence to a predicate device, while the UDI system ensures traceability and identification of medical devices in the market.
How are Biocare Systems, Inc.’s devices classified under FDA regulations?
Biocare Systems, Inc.’s infrared phototherapy units fall under Class II classification by the FDA. This classification typically applies to devices that pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness, such as performance standards or post-market surveillance.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 046121964
Catalogue (4)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Lumiwave | DLW2X4 | FDA UDI | Class II | Active |
| Lumiwave | SLW1X4 | FDA UDI | Class II | Active |
| Lumiwave 1x4 Infrared Therapy Device | K051816 | FDA 510(k) | Class II | Active |
| Biocare Systems Premir 818 | K042532 | FDA 510(k) | Class II | Active |
Related Companies
Authorised Representatives
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FDA Recalls (1)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Biocare Systems, Inc. has one FDA recall record initiated on 2006-06-14, which is listed with a terminated status. The recall was due to an electrical safety hazard associated with the AC adapter, where pulling on the cord may cause the prongs to detach, potentially damaging the unit.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Jun 14, 2006 | Z-1419-06 | — | terminated | Electrical Safety Hazard-when pulling on the cord of the AC adapter, to remove it from an outlet, the prongs on the AC adapter, may detach from the unit, damaging it and exposing the user to an electrical safety hazard |