(1056 days)
Not Found
No
The description focuses on the ultrasonic mechanism and adjustable operating features (amplitude, frequency, modes) without mentioning any AI/ML components or capabilities.
Yes
The device is intended for the fragmentation and emulsification of subcutaneous fatty tissues for aesthetic body contouring, which is a therapeutic intervention.
No
The device description and intended use clearly state that the LipoSaver™ is an ultrasonic surgical unit used for fragmentation and emulsification of subcutaneous fatty tissues for aesthetic body contouring, which is a treatment procedure, not a diagnostic one.
No
The device description explicitly details hardware components, including a handpiece with PZT ceramic crystals and a probe, which are essential for its function of fragmenting and emulsifying tissue. It is an ultrasonic surgical unit, not a software-only device.
Based on the provided information, the LipoSaver™ is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the "fragmentation and emulsification of subcutaneous fatty tissues for aesthetic body contouring" and for use in surgical procedures. This is a direct surgical intervention on the body.
- Device Description: The device description details an ultrasonic surgical unit that uses vibrations to break down tissue. This is a physical process applied to the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue samples) outside the body to provide information about a patient's health. The LipoSaver™ does not perform any such analysis of specimens.
The LipoSaver™ is clearly a surgical device used for a procedure performed directly on the patient's body.
N/A
Intended Use / Indications for Use
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
Product codes
MUU
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)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
subcutaneous fatty tissues
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Plastic and Reconstruction Surgery, Orthopedic Surgery
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Safety tests of the LipoSaver™ have demonstrated its compliance with applicable requirements of the following electrical standards:
Biocompatibility tests: Cytotoxicity test (ISO 10993-5), Intracutaneous reactivity test (ISO 10993-10), Skin sensitization test (ISO 10993-10), Acute Systemic Toxicity test (ISO 10993-11), Pyrogenicity (USP 43 )
Electrical Safety tests: Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance (IEC-60601-1), EMC Test (EN 60601-1-2).
Results: IEC 60601-1:2005/AMD2:2020: Pass, Output acoustic power: 0~40W Max±20%
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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).
1
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
2
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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3
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:
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
4
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 |
5
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, 330mm | ||
| Ø2.9, 315mm | |||
| Ø1.9, 121mm | 1~6mm diameter | ||
| 7~40cm length | Similar | ||
| Performance Data: Safety and Performance | |||
| Performance | Proposed device | Predicate Device | |
| K190551 | 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 for | ||
| Use | 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 | The VASERlipo System is intended for the | |
| fragmentation and emulsification of | ||
| subcutaneous fatty tissues for aesthetic body | ||
| contouring. The VentX console is intended | ||
| for the suction or aspiration of fluids and | ||
| tissue during surgical procedures. The | ||
| VentX console is designed to operate with | ||
| soft tissue is desired: |
- Plastic and Reconstruction Surgery
- Orthopedic Surgery | the VASERlipo System or as a stand-alone
system. The VASERlipo System is intended
for the fragmentation, emulsification and
aspiration of subcutaneous fatty tissue for
the purpose of aesthetic body contouring.
The VASERlipo System is also indicated for
use in the following surgical specialties for
the fragmentation, emulsification and
aspiration of soft tissues:
• Neurosurgery
• Gastrointestinal and affiliated organ
surgery
• Urological surgery
• Plastic and reconstructive surgery
• General surgery
• Orthopedic surgery
• Gynecological surgery
• Thoracic surgery and
• Laparoscopic surgery |
| | | |
| Key Differences between K212969 and K190551 | | |
| Primary
Function | Fragmentation and emulsification
of subcutaneous fatty tissues for
aesthetic body contouring. | Fragmentation and emulsification of
subcutaneous fatty tissues for aesthetic
body contouring. |
| Indicated
Surgeries | • Plastic and reconstructive surgery
• Orthopedic surgery | • Neurosurgery
• Gastrointestinal and affiliated organ
surgery
• Urological surgery
• Plastic and reconstructive surgery
• General surgery
• Orthopedic surgery
• Gynecological surgery
• Thoracic surgery and
• Laparoscopic surgery |
| Additional
Functionality of
K190551 | N/A | • The VentX console, part of the VASERlipo
System, is intended for the suction or
aspiration of fluids and tissue during surgical
procedures.
• The VentX console can operate with the
VASERlipo System or as a stand-alone
system |
6
:: 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.
7
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 |
| Electrical safety test | ||
| 1 | Medical Electrical Equipment - Part 1: General Requirements | |
| For 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.