Home GUDID 08809932290105 NeoSculpt Plus
Primary DI 08809932290105
Brand NeoSculpt Plus
Company S&M Medical Co., Ltd.
Model Handpiece 40
Device description This component is the Handpiece 40 of the NeoSculpt Plus. The NeoSculpt Plus is a medical device designed for use by medical professionals in hospital settings. It delivers Radiofrequency (RF) energy to a patient for therapeutic treatment. The system is composed of a main console, one or more RF handpieces that connect to the console via umbilical cables, and neutral electrodes that attach to the patient's skin. The NeoSculpt Plus provides topical heating to elevate tissue temperature, which can be used to treat various medical conditions, including the relief of pain and muscle spasms and to increase local circulation. The system operates by generating a high-frequency current that flows from the handpiece, through the patient's body (which acts as a resistance), and back to the console via the neutral electrode. This intensive current flow generates a heating profile that produces a moderate temperature rise in the subcutaneous tissue.
Published 2026-10-09
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false
Product Codes# Code, Name table Code Name PBX Massager, Vacuum, Radio Frequency Induced Heat
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class PBX Massager, Vacuum, Radio Frequency Induced Heat General, Plastic Surgery 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 08809932290037 Package GS1 6 In Commercial Distribution 08809932290105 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 08809932290037 08809932290037 8809932290037 08809932290105 08809932290105 8809932290105
Device Sizes# Type, Value, Unit table Type Value Unit Depth 0 Height 0 Width 0
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Atmospheric Pressure 0 0 Handling Environment Humidity 0 0 Handling Environment Temperature 0 0 Storage Environment Atmospheric Pressure 0 0 Storage Environment Humidity 0 0 Storage Environment Temperature 0 0
Regulatory Flags# DUNS number 694736469 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch false Serial number true Manufacturing date on label true Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 08809932290075 NeoSculpt Plus S&M Medical Co., Ltd. PBX 2026-10-20 B108499AP1MRA1MUS00 Large applicator BTL INDUSTRIES LIMITED PBX 2026-10-20 B108499AP1MRA2MUS00 Small applicator BTL INDUSTRIES LIMITED PBX 2026-10-20 B108499AP1MRA45MUS00 Edge applicators BTL INDUSTRIES LIMITED PBX 2026-10-20 B108499PO1MUS00 BTL-499-1 BTL INDUSTRIES LIMITED PBX 2026-10-20 B108890APMMUS00 EMFACE controller BTL INDUSTRIES LIMITED PBX 2026-10-12 08809932290082 NeoSculpt Plus S&M Medical Co., Ltd. PBX 2026-10-09 08809932290099 NeoSculpt Plus S&M Medical Co., Ltd. PBX 2026-10-09 08809932290112 NeoSculpt Plus S&M Medical Co., Ltd. PBX 2026-10-09 08809932290129 NeoSculpt Plus S&M Medical Co., Ltd. PBX 2026-10-09 08809932290136 NeoSculpt Plus S&M Medical Co., Ltd. PBX 2026-10-09 08809932290143 NeoSculpt Plus S&M Medical Co., Ltd. PBX 2026-10-09 00872320007218 Sveltiva CAO GROUP, INC. PBX 2026-10-01 08032625821120 GLOBUS DOMINO SRL PBX 2026-09-19 B108890POAMUS00 BTL-890U BTL INDUSTRIES LIMITED PBX 2026-08-26 08809851470145 Wavefacial WEERO Co., Ltd. PBX 2026-06-22 06974223650141 WinForth Shenzhen Leaflife Technology Co., Ltd. PBX 2026-04-22 07290016746402 V-FR Handpiece VIORA LTD PBX 2026-04-19 07290016746501 V-FR Tip VIORA LTD PBX 2026-04-19 00810060832851 Venus Nova Venus Concept Inc. PBX 2026-04-15 00850055552494 BellaTform Applicator Inbella Medical Inc PBX 2026-04-02 00850055552180 BellaPlus90 Applicator Inbella Medical Inc PBX 2026-03-30 00850055552715 i-BellaForma Applicator Inbella Medical Inc PBX 2026-03-30 00850055552005 BellaBodyFX Applicator Inbella Medical Inc PBX 2026-03-26 00850055552036 BellaForma Applicator Inbella Medical Inc PBX 2026-03-26 00850055552043 BellaPlus Applicator Inbella Medical Inc PBX 2026-03-26 00850055552067 BellaMiniFX Applicator Inbella Medical Inc PBX 2026-03-26 00850055552470 InBellaBody System Inbella Medical Inc PBX 2026-03-25 00850055552555 InBellaMax System Inbella Medical Inc PBX 2026-03-25 08056182720634 SUPERCHARGE HYDRA FASCIA ELECTRODES UNIBELL SRL PBX 2026-03-16