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Sun Flower Solette Minette Nova Super 28x, Pro Ser

FDA 510(k)

Class II (US FDA 510(k))

510(k) K851408

by Applied Science, Inc.

Identifiers

510(k) Number
K851408 FDA 510(k)
FDA Product Code
FTC FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4630 FDA 510(k)
Regulation Number
878.4630 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

This device is a Light, Ultraviolet, Dermatological, classified under FDA regulation 878.4630. It is designed for dermatological applications, specifically emitting ultraviolet light for therapeutic or cosmetic skin treatments. The device falls under Class II medical devices, requiring premarket notification (510(k)) clearance for commercial distribution.

The Sunflower Solette Minette Nova Super 28X PRO SER is intended for use in controlled clinical or cosmetic settings, supplied as a reusable medical device. It was granted FDA 510(k) clearance under the Traditional review pathway in 1985, with a Substantially Equivalent determination by the General, Plastic Surgery advisory committee. No specific sterility or MRI safety information is provided in the available data, and its dimensions or storage requirements are not detailed beyond the model designation.

Frequently asked questions

What types of skin treatments can this device be used for, and in what settings is it typically employed?

The Sunflower Solette Minette Nova Super 28X PRO SER is designed for dermatological applications, specifically emitting ultraviolet light for therapeutic or cosmetic skin treatments. It is intended for use in controlled clinical or cosmetic settings, such as dermatology offices or specialized treatment centers.

Is this device single-use or reusable, and what does that mean for maintenance and cleaning?

This device is classified as reusable, meaning it is intended for repeated use after proper cleaning and maintenance. Since it is not specified as sterile, it should be cleaned and disinfected according to manufacturer guidelines between uses to ensure safety and effectiveness.

How was the regulatory approval for this device determined, and what does that mean for its safety and equivalence?

The device received FDA 510(k) clearance under the Traditional review pathway in 1985, with a determination of Substantially Equivalent by the General, Plastic Surgery advisory committee. This means the FDA found it to be as safe and effective as a legally marketed device that served as its predicate, ensuring it meets regulatory standards for safety and performance.

Are there any known limitations or special considerations regarding storage or handling of this device?

The provided data does not specify storage requirements beyond the model designation, so storage conditions should follow general guidelines for medical devices—such as protecting it from physical damage, extreme temperatures, and contamination. Since it is reusable, proper maintenance and cleaning protocols must be followed to ensure longevity and safety.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: api.fda.gov, Applied Science, Inc. - HaRi, Applied Science Inc FDA Filings, Solana P700 Gas Springs - Tanning Bed Parts - Tanning Bulbs - Acrylic ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Applied Science, Inc.

Sources (1)

  • FDA 510(k) K851408 24 fields · synced Sep 18, 2026