SORING GMBH SONOCA LIPO

K052183 · Soring GmbH Medizintechnik · QPB · Oct 7, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K052183
• Device Name: SORING GMBH SONOCA LIPO
• Applicant: Soring GmbH Medizintechnik
• Product Code: QPB · General, Plastic Surgery
• Decision Date: Oct 7, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.5040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SONOCA Lipo is an instrument indicated for selected ultrasound dissection, liquefaction, emulsifying and aspiration of soft tissues in General Surgery, Plastic and Reconstructive Surgery, and Gynecological Surgery applications. It is also indicated for the liquefaction and aspiration of localized subcutaneous fatty tissue for aesthetic body contouring. Typical users of this system are trained medical professionals.

Device Story

SONOCA Lipo is an ultrasonic surgical system for soft tissue dissection and lipoplasty. Device consists of ultrasonic generator, infiltration pump, and aspiration pump; trolley-mounted or desktop configuration. Operates by transmitting power from a longitudinal vibrating probe tip to tissue; probe integrates irrigation and aspiration to collect cell/tissue fragments. Used by trained medical professionals in surgical settings. Provides selective tissue dissection based on ultrasonically induced cutting effect, targeting parenchyma-rich organs while sparing sustentacular tissue. Acts as a supplementary tool to conventional surgery for body contouring and soft tissue management.

Clinical Evidence

Bench testing only. Device tested for compliance with UL 2601-1, EN 60601-1, EN 60601-1-2, IEC 950, CISPR 22, IEC 801-2/3, IEEE 1003, IEC 601-1, IEC 601-2-2, and DIN EN 61847.

Technological Characteristics

Ultrasonic surgical system; includes ultrasonic generator, infiltration pump, and aspiration pump. Features longitudinal vibrating probe tip for tissue interaction. Trolley-mounted or desktop form factor. Complies with electrical safety standards (IEC 601-1, IEC 601-2-2) and electromagnetic compatibility standards (EN 60601-1-2, CISPR 22).

Indications for Use

Indicated for soft tissue dissection, liquefaction, emulsification, and aspiration in general, plastic, reconstructive, and gynecological surgery; also indicated for liquefaction and aspiration of subcutaneous fatty tissue for aesthetic body contouring in trained medical professionals.

Regulatory Classification

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 of 1/3 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.

Special Controls

*Classification.* Class II (special controls). Consensus standards and labeling restrictions.

Predicate Devices

• SORING GMBH, SONOCA 300 (K992026)
• MISONIX INC. LYSONIX 2000/3000 ULTRASONIC SURGICA (K041058)

Submission Summary (Full Text)

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Soring Gmbh Medizintechnik Carl Alletto Submission Correspondent 1600 Manchester Way Corinth, Texas 76210

June 8, 2021

Re: K052183

Trade/Device Name: Soring Gmbh Sonoca Lipo Regulation Number: 21 CFR 878.5040 Regulation Name: Suction lipoplasty system Regulatory Class: Class II Product Code: QPB

Dear Carl Alletto:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated October 7, 2005. Specifically, FDA is updating this SE Letter because FDA has created a new product code to better categorize your device technology.

Please note that the 510/k) submission was not re-reviewed. For questions regarding this letter please contact Cindy Chowdhury, OHT4: Office of Surgical and Infection Control Devices, 240-402-6647, [e-mail].

Sincerely,

Cindy Chowdhury -S

Cindy Chowdhury, Ph.D., M.B.A. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Public Health Service

OCT 7 - 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Soring GmbH Medizintechnik c/o Mr. Carl Alletto 1600 Manchester Way Corinth, Texas 76210

Re: K052183

Trade/Device Name: Soring, SONOCA-Lipo Regulation Number: 21 CFR 878.5040 Regulation Name: Suction lipoplasty system Regulatory Class: II Product Code: MUU Dated: August 7, 2005 Received: August 15, 2005

Dear Mr. Alletto:

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 (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. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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## Page 2-Mr. Carl Alletto

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours

Barbara Inelund
for
Mark N. Molkerson

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### Indications for Use

510(k) Number (if known):

Device Name: Soring, SONOCA-Lipo

Indications for Use:

The SONOCA Lipo is an instrument indicated for selected ultrasound dissection, liquefaction, emulsifying and aspiration of soft tissues in General Surgery, Plastic and Reconstructive Surgery, and Gynecological Surgery applications. It is also indicated for the liquefaction and aspiration of localized subcutaneous fatty tissue for aesthetic body contouring.

Typical users of this system are trained medical professionals.

Prescription Use VV (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

(Posted November 13, 2003)

Oevbara Bacheupformm
(Division Sign Off)

Division of General, Restorative, and Neurological Devices

**510(k) Number** K052183

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0C1 7 - 2005

K052183 Page 1/2

## 510(k) Summary of Safety & Effectiveness

(as required by 21 CFR 807.92c)

Date Prepared:

August 7, 2005

#### Submitter's Information:

Soring GmbH Medizintechnik Justus-v.Liebig 10 25451 Quickborn Germany

Telephone: [phone] Fax: [phone] Email: [e-mail]

#### Trade Name, Common Name, Classification:

| Trade name: | Soring GmbH, Sonoca™-Lipo |
|----------------------|---------------------------------|
| Common name: | Instrument, Ultrasonic Surgical |
| Classification name: | General and Plastic Surgery |

## Predicate Device:

| DEVICE CLASSIFICATION<br>NAME | PUMP, PORTABLE,<br>ASPIRATION (MANUAL OR<br>POWERED) | SYSTEM, SUCTION,<br>LIPOPLASTY |
|-------------------------------|------------------------------------------------------|---------------------------------------------------------|
| REGULATION NUMBER | 878.4780 | 878.5040 |
| 510(K) NUMBER | K992026 | K041058 |
| DEVICE NAME | SORING GMBH, SONOCA<br>300 | MISONIX INC. LYSONIX<br>2000/3000 ULTRASONIC<br>SURGICA |
| APPLICANT | SORING GMBH | MISONIX, INC. |
| PRODUCT CODE | BTA AND LFL | MUU |
| DECISION DATE | 09/23/1999 | 05/17/2004 |

#### Device Description:

SONOCA Lipo™ is a modified version of the SONOCA 300 cleared by FDA under K992026 and can be used in two ways:

- 1. As an ultrasonic dissector / aspirator as in the SONOCA 300 to cut, irrigate, and suction at the surgical site and
- 2. As an alternative to conventional Lipectomy because it is a combination of a standard Lipectomy suction device and an Ultrasound assisted Lipectomy for the selective dissection of human fatty tissue.

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K052183 page 2/2

# 510(k) Summary of Safety & Effectiveness

(as required by 21 CFR 807.92c)

The SONOCA Lipo™ is not an alternative to conventional surgery but a supplementary tool which provides an advantage for the selective dissection of human tissue.

The advantage of the SONOCA is that the tissue selectivity of the ultrasonically induced cutting effect limits the spectrum to organs with a large proportion of parenchyma in which sustentacular tissue is only minimally developed

During the use of an ultrasonic dissector, power is transmitted from a longitudinal vibrating probe tip in the contact zone to tissue. The probe with the integrated aspiration/irrigation function collects the cell and tissue fragments.

The SONOCA Lipo™ can be trolley mounted or a desktop unit consisting of an ultrasonic generator, an infiltration pump and an aspiration pump. The nodular build of the electronic components allow the unit to function at a high capacity, totally free of electronic maintenance.

## Indications for Use:

The SONOCA Lipo™ is an instrument indicated for selected ultrasound dissection, liquefaction, emulsifying and aspiration of soft tissues in General Surgery, Plastic and Reconstructive Surgery, and Gynecological Surgery applications. It is also indicated for the liquefaction and aspiration of localized subcutaneous fatty tissue for aesthetic body contouring. Typical users of this system are trained medical professionals.

## Performance Data:

The subject and predicate devices have been designed and tested to pass the following Voluntary Standards: UL 260 1-1 Medical Electrical Equipment, Part 1: General Requirements for Safety EN 60601-1 Medical Electrical Equipment, Part 1: General Requirements for Safety EN 60601-1-2:1993 Electromagnetic Compatibility and FGC Part 18 EMC Requirement. The subject device complies with IEC 950 - Safety of Information Technology Equipment, CISPR 22, class A -- Electromagnetic Compatibility, IEC-801-2, IEC-801-3 - Electromagnetic Compatibility, IEEE 1003 . - General Pelectrical Safety for medical devices, IEC 601-1 -Electrical Safety for medical devices using RFpower, IEC 601-2-2- Ultrasonic surgical devices, DIN EN 61847

## Conclusion:

Similar to the predicate devices, the SONOCA Lipo™ does not control any life sustaining functions or services. The new device and the predicate devices share the same conformance to performance standards and both function as Ultrasonic Dissectors. Based on the information supplied in this 510(k), we conclude that the subject device is safe, effective, and substantially equivalent to the predicate device.