Device
LSSA is intended for the fragmentation and emulsification of subcutaneous fatty tissues for aesthetic body contouring LSSA is indicated for use in the following surgical specialist...
Manufacturer
Newpong
Newpong
Model: NP-200
Catalog: NP-200
DI: 08800028800031
Status: New
MRI: MR Unsafe
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-06
Current Version: 2026-05-14
Description
LSSA is intended for the fragmentation and emulsification of subcutaneous fatty tissues for aesthetic body contouring LSSA is indicated for use in the following surgical specialists when the fragmentation and aspiration of adipose tissue is desired: - Plastic and Reconstruction Surgery. - Orthopedic Surgery.
Sterilization
Method Types - Sterilization Method:
Moist Heat or Steam Sterilization
Device Sterile:
No
Sterilization Prior To Use:
Yes
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
ecd8f6b9-fb28-4ee2-a4e8-10b7baf55322
Distribution Status:
In Commercial Distribution
DUNS Number:
688842613
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
Yes
Identifiers
Device ID:
08800028800031
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 44778
Name: Soft-tissue ultrasonic surgical system
Definition:
An assembly of devices that converts high frequency current into ultrasonic oscillation to mechanically fragment soft-tissue cells upon contact with a vibrating tip for cutting and/or coagulating tissue during surgery, possibly in combination with irrigation and aspiration. Ongoing vibration may create heat in cells (diathermy) to increase the cutting/coagulating capacity. It typically includes an energy-producing generator with monitoring functions, a handpiece(s) with tip(s) to convert and apply the energy, connecting cables, a foot-switch as an option to regulate the energy, and possibly an integrated irrigation/suction system.
FDA Product Codes
QPB
System, Suction, Lipoplasty For Removal
Premarket Submissions
Submission Number:
K252495
Supplement Number:
000