LYSONIX SUCTION LIPOPLASTY SYSTEM

K980771 · Lysonix, Inc. · QPB · Jul 13, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K980771
• Device Name: LYSONIX SUCTION LIPOPLASTY SYSTEM
• Applicant: Lysonix, Inc.
• Product Code: QPB · General, Plastic Surgery
• Decision Date: Jul 13, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.5040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The LySonix Suction Lipoplasty System is intended for use in aesthetic body contouring.

Device Story

Lysonix Suction Lipoplasty System is a surgical device used for aesthetic body contouring. It consists of an aspiration pump, aspiration cannulas, sterile tubing set, microbial filter, collection canisters, and canister liners. The system operates by applying suction to remove adipose tissue during lipoplasty procedures. It is intended for use by physicians in a clinical or surgical setting. The device assists the surgeon in body contouring by facilitating the removal of fat deposits, potentially improving patient aesthetic outcomes.

Clinical Evidence

No clinical data provided; substantial equivalence is based on device description and comparison to existing suction lipoplasty systems.

Technological Characteristics

System components include an aspiration pump, cannulas, tubing, microbial filter, and collection canisters. Operates via mechanical suction. Class II device, product code OPB (formerly MUU).

Indications for Use

Indicated for aesthetic body contouring in patients requiring suction-assisted fat removal.

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

• Suction lipoplasty systems (21 CFR 878.5040)

Submission Summary (Full Text)

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June 8, 2021

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Lysonix, Inc. Ronald Lagerquist Regulatory Affairs Manager 1170 Mark Ave. Carpinteria, California 93013

Re: K980771

Trade/Device Name: Lysonix Suction Lipoplasty System Regulation Number: 21 CFR 878.5040 Regulation Name: Suction lipoplasty system Regulatory Class: Class II Product Code: OPB

Dear Ronald Lagerquist:

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 July 13, 1998. 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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JUL 1 3 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Ronald F. Lagerquist Regulatory Affairs Manager Lysonix, Inc. 1170 Mark Avenue Carpinteria. California 93013

K980771 Re: Trade Name: Lysonix Suction Lipoplasty System Regulatory Class: II Product Code: MUU Dated: May 19, 1998 Received: May 22, 1998

Dear Mr. Lagerquist:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Lagerquist

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## INDICATIONS FOR USE

Applicant:

LySonix, Inc.

510(k) Number:

1980771

Device Name:

.

. ··

LySonix Suction Lipoplasty System

Indications For Use:

The LySonix Suction Lipoplasty System is intended for use in aesthetic body contouring.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|-----------------------------------------|---------|
| Division of General Restorative Devices | |
| 510(k) Number | K980771 |

| Prescription Use<br>Per 21 CFR 801.109 | <div style="text-align:center;">OR</div> | Over-the-Counter |
|----------------------------------------|------------------------------------------|------------------|
|----------------------------------------|------------------------------------------|------------------|

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TUL 1 3 1998

K980771

## 510(k) SUMMARY

This 510(k) summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92

| Submitted by: | Ronald F. Lagerquist<br>Regulatory Affairs Manager |
|---------------|----------------------------------------------------|
| | LySonix Inc. |
| | 1170 Mark Avenue |
| | Carpinteria, CA 93013 |

Telephone: [phone] [phone] FAX:

February 25, 1998 Date Prepared:

Device Name:

Proprietary Name: LySonix Suction Lipoplasty System

Common Name: Suction Lipoplasty System

Indication for Use:

The LySonix Suction Lipoplasty System is intended for use in aesthetic body contouring.

#### Device Description:

The LySonix Suction Lipoplasty System consists of an Aspiration Pump, Aspiration Cannulas, Sterile Tubing Set, Microbial Filter, Collection Canisters, and Canister Liners.

### Substantial Equivalence:

The LySonix Suction Lipoplasty System is substantially equivalent to suction lipoplasty systems described in 21 CFR § 878.5040. The components of the LySonix Suction Lipoplasty System have been found to be substantially equivalent in previously submitted LySonix Inc. 510(k) notifications.