I-LIPO, MODELS A00-1238 (230V), A00-1239 (120V)

K101366 · Chromogenex Technologies, Ltd. · NUV · Sep 17, 2010 · General, Plastic Surgery

Device Facts

• Record ID: K101366
• Device Name: I-LIPO, MODELS A00-1238 (230V), A00-1239 (120V)
• Applicant: Chromogenex Technologies, Ltd.
• Product Code: NUV · General, Plastic Surgery
• Decision Date: Sep 17, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Chromogenex Technologies Limited i-lipo™ Ultra Vacuum Massage System is indicated for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasms, temporary improvement of local blood circulation, and temporary reduction in the appearance of cellulite. The i-lipo™ Ultra Treatment Pads and Probes are indicated for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasms, and temporary improvement of local blood circulation.

Device Story

i-lipo™ Ultra System combines vacuum massage with laser diode therapy. Main unit houses power supply, pump, and control circuits; applied parts include massage head with rollers and laser diode cluster probes/pads. Device operates by placing probes/pads against patient skin; laser light provides topical heating to increase tissue temperature; rollers and vacuum provide mechanical tissue manipulation. Used in clinical settings; operated by healthcare professionals. Output is thermal and mechanical stimulation of tissue. Benefits include temporary pain relief, spasm reduction, improved circulation, and cellulite appearance reduction.

Clinical Evidence

No clinical data provided. Evidence limited to bench testing, specifically skin temperature measurements to support the performance of pads and probes as thermal heating systems.

Technological Characteristics

System includes main unit, massage head with rollers, and laser diode cluster probes/pads. Energy source: laser light (therapeutic) and vacuum (mechanical). Safety standards: IEC/UL 60601-1 (General Safety), IEC 60601-2-22 (Laser equipment), IEC 60601-1-2 (EMC), CSA C22.2. Control system includes LCD display, membrane buttons, emergency stop, and key switch.

Indications for Use

Indicated for temporary relief of minor muscle aches/pain, muscle spasms, improvement of local blood circulation, and reduction in appearance of cellulite. Applicable to general patient population seeking these therapeutic benefits.

Regulatory Classification

Identification

(1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.

Predicate Devices

• Biocellulase Smoothshapes (K061603)
• Meridian Co. Ltd Lapex BCS (K081962)

Submission Summary (Full Text)

{0}------------------------------------------------

Chromogenex Technologies Limited - i-lipo™ Ultra -Traditional 510(k) Application May 2010

# 510(k) Summary

SEP 1 7 2010

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

The assigned 510(k) number is: K0101366

#### Submitter: A.

Chromogenex Technologies Limited Units 1-2 Heol Rhosyn Parc Dafen Llanelli Carmarthenshire SA14 8QG nk

Phone: [phone] Fax: [phone]

Contact: Mr Peter R Bevan (Quality Manager)

Date Prepared: May 2010

## B. Device Names:

Classification name Common/usual name Proprietary name

Massager, vacuum, Light Induced Heating Massager / shaper i-lipo™ Ultra System

#### C. Predicate Devices:

Biocellulase Smoothshapes - K061603 Meridian Co. Ltd Lapex BCS - K081962

#### D. Device Description:

The i-lipo™ Ultra System consists of a main unit, and applied parts (massage head with rollers and various laser diode cluster probes and pads). The Main Unit contains the mains input, fuses, power supply, purmp, relay, control circuits, LCD display, membrane function buttons, emergency stop, and key switch. The massage head, and cluster probes and pads, which are placed against the patients skin, contain the rollers, and Laser diodes, Laser light provides topical heating which increases tissue temperature, and the rollers in combination with the vacuum mechanically manipulate the tissue.

#### Intended Use: ﻧﻨﺎ

The Chromogenex Technologies Limited i-lipo™ Ultra Vacuum Massage System is indicated for the temporary relief of minor muscle aches and pain, temporary relief of

{1}------------------------------------------------

Chromogenex Technologies Limited - i-lipo™ Ultra -Traditional 510(k) Application May 2010

muscle spasms, temporary improvement of local blood circulation, and temporary reduction in the appearance of cellulite.

The i-lipo™ Ultra Treatment Pads and Probes are indicated for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasms, and temporary improvement of local blood circulation.

### F. Comparison with the Predicate Devices:

The i-lipo™ Ultra is substantially equivalent to the predicates with respect to intended use and technological characteristics.

### G. Clinical Testing

. 4

Skin temperature measurements were made to support the performance of pads and probes as thermal heating systems for pain relief.

### H. Non Clinical Testing

Safety testing is to be carried out to IEC and UL 60601-1 Medical Electrical Equipment Part 1 - General Requirements for Safety; Collateral Standard : Safety Requirements for Medical Electrical Systems, IEC 60601-2-22 Specification for diagnostic and therapeutic laser equipment, CSA C22.2 Canadian Electrical code Part II, and IEC 60601-1-2 - Collateral Standard : Electromagnetic Compatibility.

#### 1. Conclusion

Based on the technological characteristics and the non clinical testing, the i-lipo™ Ultra is substantially equivalent to the above names predicate devices, for the intended use.

{2}------------------------------------------------

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure with three arms or wings extending upwards.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Chromogenex Technologies, Ltd. % Mr. Peter R. Bevan Units 1 & 2 Heol Rhosyn Parc Dafen Carmarthenshire SA14 8QG United Kingdom

Re: K101366

Trade/Device Name: i-lipo" Ultra System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II

Product Code: NUV, ILY Dated: September 13, 2010 Received: September 15, 2010

Dear Mr. Bevan:

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. 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.

SEP 1 7 2010

{3}------------------------------------------------

Page 2 - Mr. Peter R. Bevan

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 (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

for Poto thimón

Mark N. Me Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Chromogenex Technologies Limited - i-lipo™ Ultra -Traditional 510(k) Application May 2010

# Indications for Use

510(k) Number (if known): K 101366

Device Name: _ i-lipo™ Ultra System

SEP 1 7 2010

Indications for use:

The i-lipo™ Ultra - Vacuum Massage System - is indicated for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasms, temporary improvement of local blood circulation, and temporary reduction in the appearance of cellulite.

The i-lipo™ Ultra -Treatment Pads and Probes - are indicated for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasms, and temporary improvement of local blood circulation.

Prescription Use X (21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Neil RP Ogden for man
Division Size 800

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K101366