510(k) K251649

Device: Sunny Plus (Sunny)
Applicant: ShenB Co., Ltd.
510(k) number: K251649
Product code: NFO
Decision: Substantially Equivalent (SESE)
Decision date: 2025-09-18
Date received: 2025-05-29
Regulation: 882.5890
Classification name: Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Medical specialty: Neurology
Review panel: Neurology
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: N

Related Records

Applicant Contact

Contact: Sunny Kang
Address: Shenb Tower, 74, Achasan-Ro, Seongdong-Gu Seoul KR

FDA Registration Numbers

3001236514
3019577501
3029083714
3038373471
3014737458
3007008050
3030052852
3026264
3017953405
3039394880
1832894
3023356343
3035785623
3007744197
3007554929
3010402752
3015542954
3007238544
3013689783
3017133271
3023339103
3030234086
3029740697
3010872290
3016413636
3035374386
3001224205
3012104022
3011883032
3011644607
3016076077
9616877
3033793026
3017060146
3027651556
3015286916
3033850491
3030541658
3043749884
3004832480
3012470925
3006982887
3005698910
3012386142
3008929787
3008345424
3029944286
3042261413
3004786509
3027645761
3021177911
3036720861
9616085
3004839404
3006459199
3037341611
8040537

Source Documents

510(k) summary PDF

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K252218	MF SC GEN2 Facial Toning System	Micro Current Technology, Inc.	2025-07-18
K244004	Microcurrent Facial Device (CEC101, EE0101, EEI101)	Shenzhen Dachi Communication Co., Ltd.	2025-07-10
K250361	SmartAppGuidedTM MicroCurrent Face-Lift Pen 6 in 1	Geske Beauty Tech GmbH	2025-05-23
K243072	Préime DermaFacial (MicroT)	EMA Aesthetics , Ltd.	2025-04-01
K243587	PureLift GLOW	Xtreem Pulse, LLC	2025-03-06
K243063	Myolight Microcurrent Handpiece	Raja Trading Company, Inc.	2025-02-10
K243393	JMOON NouvelleSkin Facial Toning Device (M30U PR, M30U MW, M30U SG, M30U SK, M30U MP)	Shenzhen Ulike Smart Electronics Co., Ltd.	2025-02-03