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U.v. Sunlamp 95uf-11

FDA 510(k)

Class II (US FDA 510(k))

510(k) K870167

by Light Sources, Inc.

Identifiers

510(k) Number
K870167 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)

The UV Sunlamp 95UF-11 is a dermatological ultraviolet light device designed for medical use. Classified as a Light, Ultraviolet, Dermatological device under FDA regulations, it emits ultraviolet radiation for therapeutic applications, typically in dermatology and plastic surgery settings. Its primary function involves exposure to controlled UV light to treat skin conditions or promote healing processes.

This device is supplied as a reusable medical instrument and is regulated under FDA 510(k) clearance (K870167) with a classification of Class II. It is intended for use in clinical environments where dermatological treatments are administered, adhering to regulatory standards for ultraviolet lamps (regulation number 878.4630). No specific sterility or MRI safety information is provided in the data, and its size or storage requirements are not detailed beyond its classification as a medical ultraviolet light source.

Frequently asked questions

What is the UV Sunlamp 95UF-11 used for?

The UV Sunlamp 95UF-11 is a dermatological ultraviolet light device designed for therapeutic applications in medical settings. It emits controlled ultraviolet radiation to treat skin conditions or support healing processes, commonly used in dermatology and plastic surgery environments. The device is classified under FDA regulation 878.4630 for ultraviolet lamps, ensuring compliance with standards for safe and effective ultraviolet therapy.

Is the UV Sunlamp 95UF-11 reusable or single-use?

The UV Sunlamp 95UF-11 is supplied as a reusable medical instrument. Unlike single-use devices, this model is intended for repeated use in clinical environments, provided it is properly maintained and cleaned according to manufacturer guidelines. Reusability is common for durable medical devices like ultraviolet lamps, allowing for cost-effective use across multiple treatments.

What regulatory approval does the UV Sunlamp 95UF-11 hold?

The UV Sunlamp 95UF-11 holds FDA 510(k) clearance under the designation K870167, classified as substantially equivalent to a predicate device. This clearance confirms that the device meets FDA standards for safety and effectiveness as a Class II medical device. The approval was granted in 1987, with the device falling under the regulatory category for Light, Ultraviolet, Dermatological devices.

What are the key specifications or features of the UV Sunlamp 95UF-11?

The UV Sunlamp 95UF-11 is a dermatological ultraviolet light device intended for therapeutic exposure to controlled UV radiation. While specific technical details like wattage, wavelength range, or size are not provided in the data, it is classified under FDA regulation 878.4630 for ultraviolet lamps. The device is designed for clinical use in dermatology and plastic surgery, adhering to regulatory standards for ultraviolet therapy. For precise specifications, refer to the manufacturer’s documentation.

How should the UV Sunlamp 95UF-11 be stored?

While the data does not specify storage requirements beyond its classification as a reusable medical ultraviolet light source, general best practices for similar devices include storing the UV Sunlamp 95UF-11 in a clean, dry environment protected from direct sunlight, moisture, and extreme temperatures. Ensure the device is properly cleaned and maintained according to manufacturer instructions to preserve its functionality and safety for repeated use in clinical settings.

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: U. V. SUNLAMP 95UF-11 (K883952) — FDA 510 (k) | Innolitics, Light Sources, Inc. FDA 510 (k) Products (1985-2015), LightSources: UV Germicidal Lamp Manufacturer | LightSources

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Light Sources, Inc.

Sources (1)

  • FDA 510(k) K870167 24 fields · synced Oct 1, 2026