Data / Medical devices / New Zealand / Blockbluelight Limited
Blockbluelight Limited: FDA-registered device maker in Hamilton Waikato, New Zealand, 1 510(k) clearance
Blockbluelight Limited is registered with the FDA (registration 3017649333) in Hamilton Waikato, New Zealand. It lists 6 device types. The FDA files 1 510(k) clearance under its listings, the newest dated June 9, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3017649333
- Address
- 58 Roy Hilton Dr, Hamilton Waikato, New Zealand, 3210
- Owner or operator
- BLOCKBLUELIGHT LIMITED (10092873)
- Roles
- Exporter to the US
- First device listed
- February 28, 2025
- Registered through
- 2026
- Brand names listed
- LED Light Therapy Mask (G15, G15P, G15K, G11P, G11, G10, G13, G14, G17, VISO, PRANA, Chin2Chest, BBL-FACEMASK), Red Light Therapy Device Target Torch, Portable, Mini, Mid, Pro, Max, Mega, Mega Plus, Elite XL, Ultimate XXL, Face Mask, ScreenTime, DayMax, SunDown, NightFall
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Lamp, Infrared, Therapeutic Heating | ILY | 2 | Exporter to the US | accessdata.fda.gov |
| Lens, Spectacle (Prescription), For Reading Discomfort | NJH | 1 | Exporter to the US | accessdata.fda.gov |
| Lens, Spectacle, Non-Custom (Prescription) | HQG | 1 | Exporter to the US | accessdata.fda.gov |
| Light Based Over The Counter Wrinkle Reduction | OHS | 2 | Exporter to the US | accessdata.fda.gov |
| Over-The-Counter Powered Light Based Laser For Acne | OLP | 2 | Exporter to the US | accessdata.fda.gov |
| Sunglasses (Non-Prescription Including Photosensitive) | HQY | 1 | 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 |
|---|---|---|---|---|---|---|
| June 9, 2025 | K250830 | LED Light Therapy Mask (G15, G15P, G15K, G11P, G11, G10, G13, G14, G17, VISO, PRANA, Chin2Chest, BBL-FACEMASK) | OHS | Substantially Equivalent | Shenzhen Sungrow Led Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Lens, Spectacle (Prescription), For Reading Discomfort
- All makers of Lens, Spectacle, Non-Custom (Prescription)
- All makers of Lamp, Infrared, Therapeutic Heating
- All makers of Sunglasses (Non-Prescription Including Photosensitive)
- All makers of Light Based Over The Counter Wrinkle Reduction
- All makers of Over-The-Counter Powered Light Based Laser For Acne
Updated June 9, 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.