LipoSaver™ is intended for the fragmentation and emulsification of subcutaneous fatty tissues for aesthetic body contouring. LipoSaver™ is indicated for use in the following surgical specialists when the fragmentation and aspiration of soft tissue is desired:

Plastic and Reconstruction Surgery
Orthopedic Surgery

Device Description

LS-1000/LS-2000 is an ultrasonic surgical unit which uses ultrasound frequency vibration to fragment, emulsify subcutaneous fatty tissues. The PZT ceramic crystals in handpiece of LS-1000/LS-2000 transforms electrical signal into ultrasonic vibrations, and these vibrations transmit to the probe of LS-1000/LS-2000 which performs the function of fragmenting and emulsifying the subcutaneous fatty tissues. The LS-1000/LS-2000 is able to adjust the operating features such as vibration amplitude and frequency, and provides two modes as follows:

N mode (continuous mode)
Z mode (pulsed mode)

AI/ML Overview

This document does not describe acceptance criteria for an AI/ML device, nor does it detail a study that proves a device meets such criteria.

The provided text is an FDA 510(k) clearance letter and a 510(k) summary for a medical device called "LipoSaver™". This device is a suction lipoplasty system, which is a physical device used in surgery to fragment and emulsify subcutaneous fatty tissues. It is an ultrasonic surgical unit that uses PZT ceramic crystals to generate ultrasonic vibrations.

The 510(k) clearance process focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical performance data (electrical safety, biocompatibility) and a comparison of physical and functional characteristics. It does not involve AI/ML performance evaluation.

Therefore, the requested information regarding acceptance criteria for an AI/ML device and a study proving it meets those criteria cannot be extracted from this document.

The document details:

Device Name: LipoSaver™
Regulation Number/Name: 21 CFR 878.5040, Suction Lipoplasty System
Regulatory Class: Class II
Product Code: MUU
Predicate Device: K190551, VASERlipo System
Non-clinical tests performed: Biocompatibility (ISO 10993-5, -10, -11, USP 43 <151>), Electrical safety (IEC 60601-1), Electromagnetic Compatibility (EN 60601-1-2). These tests are typically for physical medical devices to ensure they are safe and perform as intended, not for AI/ML performance.
Comparison of technological characteristics: Operating frequency, cannula dimensions, and primary function are compared to the predicate.

None of the information requested in points 1-9 pertains to an AI/ML device or its performance study.

Summary

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August 07, 2024

LHbiomed Co., Ltd. % Peter Chung President Plus Global 300. Atwood Street Pittsburgh, Pennsylvania 15213

Re: K212969

Trade/Device Name: Liposaver Regulation Number: 21 CFR 878.5040 Regulation Name: Suction Lipoplasty System Regulatory Class: Class II Product Code: MUU Dated: October 31, 2023 Received: October 31, 2023

Dear Peter Chung:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,
Tek N.	Digitally signed by Tek N. Lamichhane -S
Lamichhane -S	Date: 2024.08.07 11:21:24 -04'00'
	Tek N. Lamichhane, Ph.D.
	Assistant Director
	DHT4B: Division of Infection Control
	and Plastic and Reconstructive Surgery Devices
	OHT4: Office of Surgical and Infection Control Devices
	Office of Product Evaluation and Quality Center for Devices and
	Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

510(k) Number (if known) K212969

Device Name LipoSaver™

Indications for Use (Describe)

Indications for Use (Describe)
LipoSaver™ is intended for the fragmentation and emulsification of subcutaneous fatty tissues for aesthetic body contouring. LipoSaver™ is indicated for use in the following surgical specialists when the fragmentation and aspiration of soft tissue is desired:

Plastic and Reconstruction Surgery
Orthopedic Surgery

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

K212969

1. Applicant

Company : LHbiomed Co., Ltd. Address : #806, Medical device Complex Center, 200, Gieopdosi-ro, Jijeong-myeon, Wonju-si, Gangwon-do, Republic of Korea Tel : +82-33-901-0411 Fax : +82-33-901-0422 Contact person : Peter Chung, 412-512-8802 Contact person address : 300, Atwood Street, Pittsburgh, PA, 15213, USA Date Prepared: July 12, 2024

2. Device Information

Trade Name : LipoSaver™ Common Name : Suction lipoplasty system Classification Name : System, Suction, Lipoplasty Product Code : MUU Regulation Number: 21 CFR 878.5040 Class of device: Class II Panel : General & Plastic Surgery Model name: LS-1000, LS-2000

3. Predicate Device

The legally marketed device to which we are claiming equivalence

: K190551, VASERlipo System Classification System, Suction, Lipoplasty Product Code: MUU Regulation Number: 21 CFR 878.5040 Class of device: II

4. Device description :

LS-1000/LS-2000 is an ultrasonic surgical unit which uses ultrasound frequency vibration to fragment, emulsify subcutaneous fatty tissues.

The PZT ceramic crystals in handpiece of LS-1000/LS-2000 transforms electrical signal into ultrasonic vibrations, and these vibrations transmit to the probe of LS-1000/LS-2000 which performs the function of fragmenting and emulsifying the subcutaneous fatty tissues. The LS-1000/LS-2000 is able to adjust the operating features such as vibration amplitude and frequency, and provides two modes as follows:

N mode (continuous mode)
Z mode (pulsed mode)

5. Indication for Use:

Plastic and Reconstruction Surgery

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K212969

Orthopedic Surgery

6. Technological characteristics

The technological characteristics of the LipoSaver are below:

Characteristic	K212969
Electrical shock	Class I, Type BF
Operating Frequency	35kHz~40kHz
	Ø3.7, 330mm
Cannula	Ø2.9, 315mm
	Ø1.9, 121mm

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K212969

7.Comparison of technological characteristics with the predicate device

K190551, VASERlipo System

The comparison of features and operation principles between LipoSaver™, Suction lipoplasty system from LHbiomed Co., Ltd., VASERlipo System, Suction lipoplasty system from Solta Medical is listed as follows:

Proprietary	Subject Device	Predicate Device	Substantially Equivalent or Not Substantially Equivalent
510(k) Number	K212969	K190551	N/A
Common Name	Suction lipoplasty system	Suction lipoplasty system	Substantially Equivalent
Trade name	LipoSaver™	VASERlipo System	N/A
Manufacturer	LHbiomed Co., Ltd.	Solta Medical	N/A
Product Classification	II	II	Identical
Protection degree and type for electrical shock	Class I, Type BF	Class I, Type BF	Identical
Operating Frequency	35kHz~40kHz	36kHz Nominal	Similar
Cannula	Ø3.7, 330mmØ2.9, 315mmØ1.9, 121mm	1~~6mm diameter7~~40cm length	Similar
Performance Data: Safety and Performance
Performance	Proposed device	Predicate DeviceK190551	Substantially Equivalent or Not Substantially Equivalent
Biocompatibility	Conformed to ISO 10993-1,ISO10993-5, ISO10993-10,and ISO 10993-11	Conformed to ISO 10993-1,ISO 10993-5, ISO 10993-10,and ISO 10993-11	Identical
Electrical Safety	Conformed to IEC 60601-1	Conformed to IEC 60601-1	Identical
Electromagnetic Compatibility	Conformed to IEC 60601-1	Conformed to IEC 60601-1	Identical

Comparison Table for IFU Statements

	Subject Device (K212969)	Predicate Device (K190551)
Indication forUse	LipoSaver™ is intended for thefragmentation and emulsification ofsubcutaneous fatty tissues foraesthetic body contouring.LipoSaver™ is indicated for use in thefollowing surgical specialists whenthe fragmentation and aspiration of	The VASERlipo System is intended for thefragmentation and emulsification ofsubcutaneous fatty tissues for aesthetic bodycontouring. The VentX console is intendedfor the suction or aspiration of fluids andtissue during surgical procedures. TheVentX console is designed to operate with
	soft tissue is desired:- Plastic and Reconstruction Surgery- Orthopedic Surgery	the VASERlipo System or as a stand-alonesystem. The VASERlipo System is intendedfor the fragmentation, emulsification andaspiration of subcutaneous fatty tissue forthe purpose of aesthetic body contouring.The VASERlipo System is also indicated foruse in the following surgical specialties forthe fragmentation, emulsification andaspiration of soft tissues:• Neurosurgery• Gastrointestinal and affiliated organsurgery• Urological surgery• Plastic and reconstructive surgery• General surgery• Orthopedic surgery• Gynecological surgery• Thoracic surgery and• Laparoscopic surgery

Key Differences between K212969 and K190551
PrimaryFunction	Fragmentation and emulsificationof subcutaneous fatty tissues foraesthetic body contouring.	Fragmentation and emulsification ofsubcutaneous fatty tissues for aestheticbody contouring.
IndicatedSurgeries	• Plastic and reconstructive surgery• Orthopedic surgery	• Neurosurgery• Gastrointestinal and affiliated organsurgery• Urological surgery• Plastic and reconstructive surgery• General surgery• Orthopedic surgery• Gynecological surgery• Thoracic surgery and• Laparoscopic surgery
AdditionalFunctionality ofK190551	N/A	• The VentX console, part of the VASERlipoSystem, is intended for the suction oraspiration of fluids and tissue during surgicalprocedures.• The VentX console can operate with theVASERlipo System or as a stand-alonesystem

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:: In summary, while the VASERlipo system has a wider range of applications, both devices are intended for the fragmentation and emulsification of subcutaneous fatty tissues for aesthetic body contouring, making the two devices substantially equivalent.

Substantial equivalence summary

The review of the indications for use and technical characteristics provided demonstrates the LipoSaver™ is substantially equivalent to the predicate device.

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8. Brief Summary of Nonclinical Tests and Results

Safety tests of the LipoSaver™ have demonstrated its compliance with applicable requirements of the following electrical standards:

No.	Test item	Test Standard
Biocompatibility test
1	Cytotoxicity test	ISO 10993-5
2	Intracutaneous reactivity test	ISO 10993-10
3	Skin sensitization test	ISO 10993-10
4	Acute Systemic Toxicity test	ISO 10993-11
5	Pyrogenicity	USP 43 <151>
Electrical safety test
1	Medical Electrical Equipment - Part 1: General RequirementsFor Basic Safety And Essential Performance	IEC-60601-1
2	EMC Test	EN 60601-1-2

No.	Test item	Result
1	IEC 60601-1:2005/AMD2:2020	Pass
2	Output acoustic power	0~40W Max±20%

9. Conclusion:

The LipoSaver™ shares the same indications for use, design features, and functional features, and thus is substantially equivalent to the predicate device. Non-clinical test results demonstrate that the LipoSaver™ is substantially equivalent to the predicate device and no new issues of safety or effectiveness have been raised.

Regulation Number and Section

§ 878.5040 Suction lipoplasty system.

(a)
Identification. A suction lipoplasty system is a device intended for aesthetic body contouring. The device consists of a powered suction pump (containing a microbial filter on the exhaust and a microbial in-line filter in the connecting tubing between the collection bottle and the safety trap), collection bottle, cannula, and connecting tube. The microbial filters, tubing, collection bottle, and cannula must be capable of being changed between patients. The powered suction pump has a motor with a minimum of1/3 horsepower, a variable vacuum range from 0 to 29.9 inches of mercury, vacuum control valves to regulate the vacuum with accompanying vacuum gauges, a single or double rotary vane (with or without oil), a single or double diaphragm, a single or double piston, and a safety trap.(b)
Classification. Class II (special controls). Consensus standards and labeling restrictions.