NeoSculpt Plus

Primary DI
08809932290112
Brand
NeoSculpt Plus
Company
S&M Medical Inc.
Model
Handpiece 16
Device description
This component is the Handpiece 16cm^2 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
New
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
CodeName
PBXMassager, Vacuum, Radio Frequency Induced Heat

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PBXMassager, Vacuum, Radio Frequency Induced HeatGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K252888000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K252888000NeoSculpt PlusS&M Medical Co., Ltd.2026-03-09PBX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809932290112PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809932290112088099322901128809932290112

GMDN Terms#

Term, Definition table
TermDefinition
Radio-frequency skin/body contouring systemAn assembly of devices that uses radio-frequency (RF) electromagnetic (EM) energy [typically in the bands below 10 megahertz (MHz)] to generate heat deep within subcutaneous tissues to temporarily minimize the manifestation of cellulite and loose or wrinkled skin through a process of skin regrowth and tightening and local fat cell alteration/destruction. It typically consists of monopolar and/or bipolar applicators attached to an energy-producing generator, typically with a cooling module. The tissues are warmed to produce the desired therapeutic effect; simultaneous cryogen cooling of the epidermis may be employed. This device is not used for the treatment of malignancies.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth0
Height0
Width0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure00
Handling Environment Humidity00
Handling Environment Temperature00
Storage Environment Atmospheric Pressure00
Storage Environment Humidity00
Storage Environment Temperature00

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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809932290082NeoSculpt PlusEmergency Cable2026-10-09
08809932290099NeoSculpt PlusNeoSculpt Plus Body2026-10-09
08809932290105NeoSculpt PlusHandpiece 402026-10-09
08809932290129NeoSculpt PlusNeoSculpt Plus2026-10-09
08809932290136NeoSculpt PlusNeutral Electrode Cable2026-10-09
08809932290143NeoSculpt PlusNeutral Electrode Pad2026-10-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08809932290099NeoSculpt PlusS&M Medical Inc.PBX2026-10-09
08809932290105NeoSculpt PlusS&M Medical Inc.PBX2026-10-09
08809932290129NeoSculpt PlusS&M Medical Inc.PBX2026-10-09
08809932290136NeoSculpt PlusS&M Medical Inc.PBX2026-10-09
08809932290143NeoSculpt PlusS&M Medical Inc.PBX2026-10-09
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