Martanique 7-TUBE RUVA Home Solarium
by Bainbridge Trading Co., Ltd.
510(k) K845028
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK845028 | Date14 Jan 1985 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- FTC
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4630
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Martanique 7-Tube RUVA Home Solarium is a dermatological ultraviolet light device designed for home use. It emits ultraviolet A (UVA) radiation through seven integrated tubes to simulate natural sunlight, primarily for therapeutic or cosmetic skin treatments such as vitamin D synthesis, psoriasis management, or general tanning.
This device is intended for non-clinical, home use and has received FDA 510(k) clearance under the classification FTC (Fair Trade Commission) and regulation 21 CFR 878.4630. It is not classified as single-use or reusable in the provided data, and no specific sterility or MRI safety information is stated. The device is supplied as a complete unit for personal use, with no additional regulatory authorisations mentioned beyond the 510(k) clearance.
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Questions
AI-generated answers, 19 Sep 2026
What is the primary purpose of the Martanique 7-Tube RUVA Home Solarium, and who is it designed for?
The Martanique 7-Tube RUVA Home Solarium is designed for home use to simulate natural sunlight through ultraviolet A (UVA) radiation. It is intended for dermatological treatments like vitamin D synthesis, psoriasis management, or cosmetic tanning. Since it is classified under 21 CFR 878.4630 and cleared via FDA 510(k), it is meant for non-clinical, personal use in a residential setting.
How is the device supplied, and does it require any additional components or accessories?
The Martanique 7-Tube RUVA Home Solarium is supplied as a complete unit for personal use, meaning no extra components or accessories are required beyond what is included in the package. The device is designed to be ready for immediate use out of the box.
Is the Martanique 7-Tube RUVA Home Solarium intended for single-use or repeated use, and what are its sterility considerations?
The provided data does not specify whether the device is single-use or reusable. Since it is a home-use dermatological UV device, proper cleaning and maintenance would be necessary if reused, though no sterility claims or guidelines are mentioned in the documentation.
What regulatory pathway was followed for the FDA clearance of this device, and what does that mean for users?
The Martanique 7-Tube RUVA Home Solarium received FDA 510(k) clearance under the Traditional 510(k) Review pathway, classified as Substantially Equivalent (SE) to a predicate device. This means the FDA determined it has the same intended use and technological characteristics as a previously cleared device, ensuring it meets safety and effectiveness standards for home UV therapy.
Are there any special handling or storage instructions mentioned for this device?
The provided data does not include specific storage instructions for the Martanique 7-Tube RUVA Home Solarium. However, since it is a UV-emitting device, it should be stored in a dry, secure location away from direct sunlight or extreme temperatures to maintain its functionality and safety.