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Sunny

FDA 510(k)

Class II (US FDA 510(k))

510(k) K242241

by shenb Co., Ltd.

Identifiers

510(k) Number
K242241 FDA 510(k)
FDA Product Code
GEI FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4400 FDA 510(k)
Regulation Number
878.4400 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Sunny is a monopolar RF device used in general and plastic surgery procedures. It is substantially equivalent to a legally marketed device and received traditional 510(k) clearance from the U.S. Food and Drug Administration.

The device is manufactured by shenb Co., Ltd. in Seoul, South Korea. It is supplied as a reusable system with two versatile handpieces and is intended for use in clinical settings under professional supervision. Storage and handling should follow the manufacturer's instructions.

Frequently asked questions

What is the Sunny device used for?

The Sunny device is a monopolar RF system intended for use in general and plastic surgery procedures, as stated in its description and advisory committee classification for those specialties.

Is the Sunny device reusable or single-use?

The Sunny device is supplied as a reusable system, meaning it is designed for multiple uses after proper reprocessing, as explicitly mentioned in the device data under its supply description.

What components are included with the Sunny device?

The Sunny device is supplied with two versatile handpieces, which are part of the reusable system intended for clinical use under professional supervision.

How should the Sunny device be stored and handled?

Storage and handling of the Sunny device must follow the manufacturer's instructions, as specified in the device data to ensure safe and effective use in clinical settings.

Who manufactures the Sunny device and where is it made?

The Sunny device is manufactured by shenb Co., Ltd. in Seoul, South Korea, as indicated in the manufacturer and address details provided in the device data.

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: SHENB's Sunny device receives FDA approval | SHENB Co., Ltd. posted on ..., Sunny — SHENB Co., Ltd. — Suplivia, ShenB Co., Ltd. FDA 510 (k) Products - Latest 2026, SUNNY - Shenb Co., Ltd. Trademark Registration, PDF September 18, 2025 ShenB Co., Ltd ℅ Aubrey Thomps

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
shenb Co., Ltd.

Sources (1)

  • FDA 510(k) K242241 24 fields · synced Sep 22, 2026