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FDA 510(k)

JMOON NouvelleSkin Facial Toning Device (M30U PR, M30U MW, M30U SG, M30U SK, M30U MP)

K-Number: K243393 · 2025-02-03

ApplicantShenzhen Ulike Smart Electronics Co., Ltd.
Decision Date2025-02-03
Product CodeNFO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

JMOON NouvelleSkin Facial Toning Device (M30U PR, M30U MW, M30U SG, M30U SK, M30U MP) is a medical device manufactured by Shenzhen Ulike Smart Electronics Co., Ltd.. It received FDA 510(k) clearance on 2025-02-03 under approval number K243393. The device is classified under product code NFO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the JMOON NouvelleSkin Facial Toning Device (M30U PR, M30U MW, M30U SG, M30U SK, M30U MP)?

JMOON NouvelleSkin Facial Toning Device (M30U PR, M30U MW, M30U SG, M30U SK, M30U MP) is a medical device that received FDA 510(k) clearance on 2025-02-03. It is manufactured by Shenzhen Ulike Smart Electronics Co., Ltd.. The 510(k) number is K243393.

When was JMOON NouvelleSkin Facial Toning Device (M30U PR, M30U MW, M30U SG, M30U SK, M30U MP) approved by the FDA?

JMOON NouvelleSkin Facial Toning Device (M30U PR, M30U MW, M30U SG, M30U SK, M30U MP) received FDA 510(k) clearance on 2025-02-03, under approval number K243393.

What company makes JMOON NouvelleSkin Facial Toning Device (M30U PR, M30U MW, M30U SG, M30U SK, M30U MP)?

JMOON NouvelleSkin Facial Toning Device (M30U PR, M30U MW, M30U SG, M30U SK, M30U MP) is manufactured by Shenzhen Ulike Smart Electronics Co., Ltd..

What is the FDA product code for JMOON NouvelleSkin Facial Toning Device (M30U PR, M30U MW, M30U SG, M30U SK, M30U MP)?

The FDA product code for JMOON NouvelleSkin Facial Toning Device (M30U PR, M30U MW, M30U SG, M30U SK, M30U MP) is NFO.

Related Clinical Trials

NCT06915402 Efficacy and Safety of "LMW - CL - HA - FACE/BODY" for the Augmentation of the Cheeks COMPLETED NCT07611643 Bruxism Therapy of Facial Pain RECRUITING NCT07585591 Safety and Efficacy Evaluation of the Xerf Device for Aesthetic Treatments COMPLETED NCT03795675 CI Following VS Removal or Labyrinthectomy ACTIVE_NOT_RECRUITING NCT06734351 A Study to Evaluate Safety and Effectiveness of NOA VOLUME Injectable Gel in Adult Participants Compared to JUVÉDERM VOLUMA XC for Improvement of Mid-Face Volume RECRUITING NCT06899711 External Post-Operative Skull Prosthesis to Prevent Sunken Flap Syndrome in Craniectomy Patients RECRUITING

Related PubMed Literature

PMID: 30005090 Straight-Line Vector Planning for Optimal Results With Silhouette InstaLift in Minimally Invasive Tissue Repositioning for Facial Rejuvenation. Journal of drugs in dermatology : JDD (2018)

Other Devices by Shenzhen Ulike Smart Electronics Co., Ltd.

K221002IPL Hair Removal Device, Model(s): UI04A, UI04B, UI04C K230122IPL Hair Removal Device, Model(s): UI04 SD, UI04 DG K223618IPL Hair Removal Device, Model(s): UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB, UI06 PR, UI06 OG, UI06 RD K241998Ice Cooling IPL Hair Removal Device (UI20 DB, UI20 RE, UI20 GP, UI20 PW, UI20S DB, UI20S RE, UI20S PW, UI20S GP,UI20 WH, UI20 GR, UI20 BS, UI20 MP, UI20 BL, UI20 PN, UI20 BR, UI20WG, UI20S WH, UI20S GR, UI20S BS, UI20S MP) K242039Ice Cooling IPL Hair Removal Device (UIM20 GR, UIM20 BK, UIM20 SL, UIM20 CB, UIM20 WR) K241205Ice Cooling IPL Hair Removal Device (Y6S GR, Y6S GA,Y6S GT, Y6S JU, Y6S JM, Y6S MU, Y6S OG, Y6S CH,Y6S PN,Y6S NK, Y6S PG, Y6S TG, Y6S OE)

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Related Devices (Code: NFO)

K152199RejuvatoneMDTrophy Skin, Inc. K150826Nutra Face Lift Model PE8050Nutra Luxe MD, LLC K163550Pobling MIITY 2Habalan Med & Beauty Co.,Ltd K162652Smart Photon Micro-current Device, Model: EP-300Li-Tek Electronic Technology Corporation K171647BeneLife Premium Facial Treatment Pack, Model: QZ0701AInfinitus (China) Company , Ltd. K171588NuBODY Skin Toning DeviceCarol Cole Company Dba Nuface

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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