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Sunflower

by Solana, Inc.

510(k) K820123

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK820123 Date1 Mar 1982ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

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

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Sunflower is a Light, Ultraviolet, Dermatological device, classified as a Class II medical product under FDA regulation 878.4630. It is designed to emit ultraviolet light for dermatological applications, including skin treatments and tanning procedures.

This device is supplied as a reusable tanning bed system with a remote timer interface module (e.g., Model #M0026). It is intended for use in controlled environments such as tanning salons or professional dermatological settings. The Sunflower received FDA 510(k) clearance (K820123) under the Traditional 510(k) pathway, with a decision date of March 1, 1982. No specific sterility or MRI safety information is provided in the available data.

Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What types of environments is the Sunflower UV tanning bed designed for, and how is it typically supplied?

    The Sunflower is designed for controlled professional settings like tanning salons or dermatological clinics. It is supplied as a reusable tanning bed system, including a remote timer interface module (e.g., Model #M0026), ensuring it can be integrated into existing salon or clinic workflows.

  • Is the Sunflower UV tanning bed intended for single-use or repeated use, and what does this mean for maintenance?

    The Sunflower is explicitly described as a *reusable* tanning bed system, meaning it is built for repeated use in professional environments. This implies it requires regular maintenance and cleaning to ensure safety and performance over time, though specific cleaning protocols or service intervals are not detailed in the provided data.

  • Are there any specific storage requirements or considerations for the Sunflower UV tanning bed?

    The provided data does not specify storage requirements for the Sunflower UV tanning bed. However, as a reusable medical device, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures to preserve its functionality and ensure longevity.

  • What regulatory pathway was used for the Sunflower’s FDA clearance, and what does this mean for its intended use?

    The Sunflower received FDA clearance under the *Traditional 510(k)* pathway, with a decision date of March 1, 1982, and was determined to be *substantially equivalent* to a predicate device. This clearance was filed under the product code *FTC* (Full Body Tanning) and classified as a Class II medical device under regulation 878.4630, indicating it is intended for dermatological applications, including tanning procedures, in professional settings.