Question 1

What types of medical devices does Blublox Pty Ltd manufacture?

Accepted Answer

Blublox Pty Ltd specializes in three primary categories of home-use devices: cosmetic red-light phototherapy systems for skin rejuvenation, electric pads designed for localized body heating, and handheld electric massagers for muscle relief. These products are intended for consumer use without requiring medical supervision or invasive procedures.

Question 2

Where is Blublox Pty Ltd based, and does that affect its regulatory standing?

Accepted Answer

Blublox Pty Ltd is based in the United States. Its regulatory standing is determined by the specific devices it manufactures and their classification under U.S. regulations, such as FDA guidelines. The company’s location influences which regulatory bodies oversee its products, but individual devices must meet their own authorization criteria.

Question 3

Which regulatory registries list Blublox Pty Ltd’s devices, and why?

Accepted Answer

Blublox Pty Ltd’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is used to track and identify medical devices under U.S. regulatory frameworks, ensuring transparency and traceability for compliance purposes. Listing in the UDI database is a requirement for devices marketed in the U.S., including those classified as Class I or Class II.

Question 4

How are Blublox Pty Ltd’s devices classified under FDA regulations?

Accepted Answer

Blublox Pty Ltd’s devices are classified under FDA regulations as either Class I or Class II. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher level of risk and may require special controls to ensure safety and effectiveness. The classification determines the regulatory pathway and oversight required for each device.

Question 5

Are Blublox Pty Ltd’s devices primarily focused on clinical or consumer use?

Accepted Answer

Blublox Pty Ltd’s devices are designed for consumer use rather than clinical applications. Examples include home-use cosmetic red-light phototherapy systems, localized heating pads, and handheld massagers, all intended for at-home or personal use without medical supervision. This distinction affects their regulatory classification and marketing scope.

Device	Model / Reference	Registries	Class	Status
Bon Charge	Demi Red Light Therapy Device	FDA UDI	Class II	Active
Bon Charge	Mini Red Light Therapy Device	FDA UDI	Class II	Active
Bon Charge	Red Light Therapy Blanket	FDA UDI	Class II	Active
Bon Charge	Max Red Light Therapy Device	FDA UDI	Class II	Active
Bon Charge	Red Light Face Mask	FDA UDI	Class II	Active
Bon Charge	PEMF Wrap	FDA UDI	Class II	Active
Bon Charge	Infrared PEMF Sauna Dome	FDA UDI	Class II	Active
Bon Charge	Cold & Heat Therapy Massage Gun	FDA UDI	Class I	Active
Bon Charge	Sauna Blanket	FDA UDI	Class II	Active
Bon Charge	Super Max Red Light Therapy Device	FDA UDI	Class II	Active
Bon Charge	PEMF Mat Max	FDA UDI	Class II	Active
Bon Charge	PEMF Mat Mini	FDA UDI	Class II	Active
Bon Charge	Red Light Face Wand	FDA UDI	Class II	Active
Bon Charge	PEMF Mat Demi	FDA UDI	Class II	Active
Bon Charge	Red Light Neck and Chest Mask	FDA UDI	Class II	Active
Bon Charge	Bullet Red Light Therapy Device	FDA UDI	Class II	Active

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