Data / Medical devices / Australia / Blublox Pty Ltd
Blublox Pty Ltd: FDA-registered device maker in Sydney New South Wales, Australia, 1 510(k) clearance
Blublox Pty Ltd is registered with the FDA (registration 3033590685) in Sydney New South Wales, Australia. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 24, 2025. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3033590685
- Address
- 18.02 60 Margaret Street, Sydney New South Wales, Australia, 2000
- Owner or operator
- BLUblox Pty Ltd (10091860)
- Roles
- Exporter to the US
- First device listed
- November 8, 2024
- Registered through
- 2027
- Brand names listed
- Bon Charge Demi Red Light Therapy Device (SG-DP), Bon Charge Infrared PEMF Mat Demi (Model: S-119), Bon Charge Infrared PEMF Mat Max (Model: S-120), Bon Charge Infrared PEMF Mat Mini (Model: S-118), Bon Charge Infrared PEMF Sauna Dome (Model: S-108), Bon Charge Infrared PEMF Wrap (Model: S-117), Bon Charge Infrared Sauna Blanket (Model: S-102), Bon Charge Max Red Light Therapy Device (SG-DP) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Lamp, Infrared, Therapeutic Heating | ILY | 2 | Exporter to the US | accessdata.fda.gov |
| Laser, Comb, Hair | OAP | 2 | Exporter to the US | accessdata.fda.gov |
| Pad, Heating, Powered | IRT | 2 | Exporter to the US | 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 24, 2025 | K253349 | Hair Regrowth Cap (Model: T-119-HRC) | OAP | Substantially Equivalent | Light Tree Ventures Europe B.V. | accessdata.fda.gov |
Compare with other makers
- All makers of Laser, Comb, Hair
- All makers of Lamp, Infrared, Therapeutic Heating
- All makers of Pad, Heating, Powered
Updated December 24, 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.