S&M MEDICAL INC.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3044778118	3044778118	S&M MEDICAL INC.	1	N	2027-01-01	Suit 212, 249 Chuam-ro, Buk-gu Gwangju KR 61003

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
349780	1656196645	K252888	NeoSculpt Plus	PBX	2026-03-09

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
PBX	1	2026-03-09

GUDID#

NeoSculpt Plus - This component is the Emergency Cable 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.
S&M Medical Inc.
2026-10-09
NeoSculpt Plus - This component is the main body (main console) 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.
S&M Medical Inc.
2026-10-09
NeoSculpt Plus - 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.
S&M Medical Inc.
2026-10-09
NeoSculpt Plus - 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.
S&M Medical Inc.
2026-10-09
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. The device is composed of Neosculpt Plus Body (Main body), Handpiece (40cm^2), Handpiece (16cm^2), Neutral Electrode Cable, Neutral Electrode Pad (Patient Kit), Emergency Cable, and Handpiece Holder.
S&M Medical Inc.
2026-10-09
NeoSculpt Plus - This component is the Neutral Electrode Cable 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.
S&M Medical Inc.
2026-10-09
NeoSculpt Plus - This component is the Neutral Electrode Pad of the NeoSculpt Plus. This is packed as a Patient Kit. This kit includes two (2) Large double sided tapes (Model No. NS-LT) and three(3) small double sided tapes (Model No. NS-ST). 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.
S&M Medical Inc.
2026-10-09