BTL-9000; BTL-9000 RADIOFREQUENCY MODULE

K134040 · Btl Industries, Ltd. · OLI · Sep 10, 2014 · General, Plastic Surgery

Device Facts

• Record ID: K134040
• Device Name: BTL-9000; BTL-9000 RADIOFREQUENCY MODULE
• Applicant: Btl Industries, Ltd.
• Product Code: OLI · General, Plastic Surgery
• Decision Date: Sep 10, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.5400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The BTL-9000 device is a low level laser system that can be used for the non-invasive temporary reduction of waist circumference by the disruption of adipocyte cells within the fat layer for the release of fat and lipids from these cells for non-invasive aesthetic use.

Device Story

BTL-9000 is a low-level laser system for non-invasive aesthetic waist circumference reduction. Device comprises a cabinet-mounted control unit with touchscreen interface and a laser applicator containing four 660 nm cold red laser diodes. Physician or technician places applicator on patient skin; laser energy penetrates to fat layer; light exposure induces pore formation in adipocytes; fat, lipids, and water are released into interstitial space; adipocyte size reduces. Device operates on 100-240V power. Healthcare provider uses device to provide a series of treatments; clinical benefit is temporary reduction in waist circumference. System is standalone; can be used with other modalities.

Clinical Evidence

Double-blind study of 30 subjects (15 treatment, 15 placebo) receiving 8 twice-weekly treatments. Primary endpoint: waist circumference reduction at 30-day follow-up. Treatment group showed mean reduction of 3.53 cm vs -0.13 cm in placebo (p-value not specified, but stated as statistically significant). Immediate post-treatment reduction was 2.13 cm vs -0.1 cm (statistically significant). No adverse events reported.

Technological Characteristics

Low-level laser system; 660 nm wavelength; 4 cold red laser-emitting diodes per applicator; 50mW ± 15% output per diode. Cabinet-mounted with wheels. Touchscreen interface. Power: 100-240V, 50-60Hz. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60601-2-22, IEC 60825-1, ISO 10993-5, ISO 10993-10, ISO 14971.

Indications for Use

Indicated for non-invasive temporary reduction of waist circumference in adults via adipocyte disruption and lipid release for aesthetic purposes.

Regulatory Classification

Identification

A Low Level Laser System for Aesthetic Use is a device using low level laser energy for the disruption of adipocyte cells within the fat layer for the release of fat and lipids from these cells for noninvasive aesthetic use.

Special Controls

*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Low Level Laser System for Aesthetic Use.” See § 878.1(e) for the availability of this guidance document.

Predicate Devices

• Strawberry & Cream Low Level Laser System (K130341)

Submission Summary (Full Text)

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Public Health Service

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

September 12, 2014

MMP Medical Associates, LLC Michail M. Pankratov, MD, PhD Regulatory Consultant for BLT Industries, Ltd. 16 Appleton Street Waltham, Massachusetts 02453

Re: K134040

Trade/Device Name: BTL-9000 Regulation Number: 21 CFR 878.5400 Regulation Name: Low Level Laser System for Aesthetic use Regulatory Class: Class II Product Code: OLI Dated: August 8, 2014 Received: August 11, 2014

Dear Mr. Pankratov:

This letter corrects our substantially equivalent letter of September 10, 2014.

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.

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

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Page 2 - Michail M. Pankratov. MD. PhD

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 (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ReportaProblem/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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# David Krause -S

for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K134040

Device Name BTL-9000

Indications for Use (Describe)

The BTL-9000 device is a low level laser system that can be used for the non-invasive temporary reduction of waist circumference by the disruption of adipocyte cells within the fat layer for the release of fat and lipids from these cells for non-invasive aesthetic use.

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

# Neil R Ogden -S 2014.09.09 16:06:09 -04'00

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## SECTION 5: 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

As required by section 807.92(c)

### I. General Information

| Submitter: | BTL Industries, Ltd<br>30 Peshtersko Shouse Blvd<br>Plovdiv 4002, Bulgaria<br>Tel: [phone]<br>Fax: [phone] |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Michail M. Pankratov, MD, PhD<br>MMP Medical Associates, LLC<br>16 Appleton Street<br>Waltham, MA 02453<br>[e-mail]<br>Tel: [phone]<br>Fax: [phone] |
| Summary Preparation Date: | August 8, 2014 |

### II. Device Information

| Trade Name: | BTL-9000 |
|----------------------|------------------------------------------|
| Common/Usual Name: | Low level Laser System for Aesthetic Use |
| Classification: | Class II<br>21 CFR 878.5400 |
| Product Code: | OLI |
| Classification Name: | Low level Laser System for Aesthetic Use |
| Device Panel: | General & Plastic Surgery |

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#### Predicate Devices lll.

| Device name | BTL-9000 | Strawberry & Cream Low Level<br>Laser System |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company<br>name | BTL Industries, Ltd. | Laser Lipo, Ltd. |
| 510(k)<br>reference | K134040 | K130341 |
| Device<br>description | Device consists of an electrically<br>powered control unit using<br>touchscreen interface. The system<br>can operate using laser applicator<br>that is connected to the control<br>unit. A laser applicator is a device<br>containing 4 cold laser red laser<br>emitting diodes. | Device consists of an electrically<br>powered control unit using<br>touchscreen interface. The system can<br>operate using 4, 6, 8 or 10 paddles<br>that are connected to the control unit.<br>A paddle is a device containing 6 cold<br>red laser emitting diodes. |
| Class | II | II |
| Product Code | OLI | OLI |
| Indications for<br>use | The BTL-9000 device is a low level<br>laser system that can be used for<br>the non-invasive temporary<br>reduction of waist circumference<br>by the disruption of adipocyte cells<br>within the fat layer for the release<br>of fat and lipids from these cells<br>for non-invasive aesthetic use. | Strawberry & Cream Low Level Laser<br>System can be used for the non-<br>invasive temporary reduction of waist<br>circumference by the disruption of<br>adipocyte cells within the fat layer for<br>the release of fat and lipids from these<br>cells for non-invasive aesthetic use. |
| Mechanism<br>of<br>Action | Disruption of adipocyte cells within<br>the fat layer for the release of fat<br>and lipids from these cells for non-<br>invasive aesthetic use. | Disruption of adipocyte cells within the<br>fat layer for the release of fat and<br>lipids from these cells for non-invasive<br>aesthetic use. |
| Power | 200 mW per applicator | 240 mW per paddle |
| Dimensions<br>W x H x D | 560 x 980 x 560 mm | 275 x 185 x 315 mm |
| Configuration | Cabinet-mounted with wheels | Table top |
| Device<br>classification | Class II, OLI, 878.5400 | Class II, OLI, 878.5400 |

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#### IV. Intended Use

The BTL-9000 device is a low level laser system that can be used for the noninvasive temporary reduction of waist circumference by the disruption of adipocyte cells within the fat layer for the release of fat and lipids from these cells for non-invasive aesthetic use.

#### V. Device Description

The BTL-9000 consists of a control unit, connection lead to a BTL-9000 Laser Applicator and other accessories. (A full list of system contents is included in the operator's manual). The Laser Applicator is containing four cold red (660 nm) laser-emitting diodes and is designed to be placed on the skin. The output of the diode (four per applicator) is limited to 50mW ± 15% by a power limiting PCB from the central processing unit. The system can operate using 1 applicator that is connected to the control unit. The control unit is an electrically powered unit (100-240V, 50-60Hz auto-ranging). Once enabled it is controlled using a touchscreen interface. When the Laser Applicator is placed on the skin, the cold red laser beams penetrate the skin just deep enough to reach the layers of fat. When the light hits the fat cells, a rapid chain of events takes place. Firstly, pores form on the cells causing them to spill out. The water, Glycerol and fatty acids move into the interstitial space beneath the fatty layer in the skin. Then further water, fatty acids and Glycerol spill out. The adipocyte cells and therefore reduced in size. The BTL-9000 is a stand-alone device which can be used together with other modalities which are not part of this submission.

#### VI . Materials

All materials used in the manufacture of the BTL-9000 have been demonstrated to meet strict design requirements, including requirements for durability and biocompatibility, and therefore suitable for use under the anticipated conditions of use associated with the device. There are no changes in materials that raise questions of safety or effectiveness.

#### VII. Testing

Based on the risk assessment of the modifications, bench testing and clinical testing were performed to ensure continued conformance to all product specifications, and equivalence to the predicate device.

The BTL-9000 module has been shown to conform to the applicable requirements of the following:

#### IEC 60601-2-22:1995 Ed.2

Medical Electrical Equipment - Part 2-22: Particular Requirements For The Safety Of Diagnostic And Therapeutic Laser Equipment.

#### IEC 60825-1:2007 Ed.2

Safety Of Laser Products - Part 1: Equipment Classification, And Requirements.

#### IEC 60601-1:1988 + A1:1991-11 +A2:1995

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

#### Confidential

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#### IEC 60601-1-2:2001 + A1:2004

Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility – Requirements and tests

#### IEC 60601-1-4:2000 Consol. Ed. 1.1

Medical electrical equipment - Part 1-4: General requirements for safety -Collateral Standard: Programmable electrical medical systems

#### ISO 10993-5:2009

Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity ISO 10993-10:2010

Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization

#### ISO 14971:2007

Medical devices - Application of risk management to medical devices

For the BTL-9000 laser wavelength and output has been demonstrated (see SECTION 18) to be capable and substantially equivalent to the predicate device (Strawberry & Cream Low Level Laser System, Laser Lipo, Ltd ; K130341).

#### Clinical Testing VIII.

Clinical study: A double blind clinical study was conducted using 30 subjects: 15 subjects received BTL-9000 LLLT treatments, and other 15 subjects received placebo treatments. Subjects in both groups received 8 twice-a-week treatments. Their waist circumference and weight were evaluated at the baseline, at the end of the 8th treatment and at 30-day follow-up after the last treatment.

Results: No adverse events were experienced by any of the subjects. All subjects in BTL-9000 LLLT met the primary endpoint of a temporary waist circumference reduction (at the height of the iliac crest) of a minimum of 3 cm at 30-day follow up as compared to the baseline evaluation. The average recorded loss was 3.53 cm vs. -0.13 cm in Placebo group and was statistically significant. This procedure also produced, average 2.13 cm reduction in waist circumference immediately posttreatment vs. -0.1 in Placebo group that was also statistically significant. The reductions were also statistically significant within the treatment group: baseline vs. post-treatment, baseline vs. 30-day follow up, and post-treatment vs. 30-day follow up.

Table VIII-1. Subjects in Treatment Group - Mean Waist Circumference and Mean Change in Waist Circumference

| | | Waist Circumference (cm) | | | Change in Waist<br>Circumference (cm) | | |
|---------|-----------------|--------------------------|-----------------|-----------------|---------------------------------------|----------------------------|--------------------------|
| | Age | Pre-Tx | Post-Tx | 30-day<br>FU | Pre-Tx<br>vs.<br>Post-Tx | Pre-Tx<br>vs.<br>30d<br>FU | Post-Tx vs.<br>30d<br>FU |
| Mean±SD | 44.73±<br>11.39 | 91.37±<br>13.14 | 89.23±<br>12.95 | 87.83±<br>13.14 | 2.13±<br>0.61 | 3.53±<br>0.40 | 1.40±<br>0.60 |

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| Median | 43 | 89 | 87.5 | 85.5 | 2 | 3.5 | 1.5 |
|-----------|---------|----------|----------|--------------|-------|-------------|-------------|
| (Min-Max) | (30-68) | (69-118) | (66-115) | (66.5-114.5) | (1-3) | (3.0 - 4.5) | (0.5 - 2.5) |

Table VIII-2. Subjects in Placebo Group - Mean Waist Circumference and Mean Change in Waist Circumference

| | | Waist Circumference<br>(cm) | | | Change in Waist<br>Circumference (cm) | | |
|------------|-----------------|-----------------------------|---------------|----------------|---------------------------------------|-------------------------|------------------------------|
| | Age | Pre-Tx | Post-<br>Tx | 30-day<br>FU | Pre-Tx<br>vs.<br>Post-Tx | Pre-Tx<br>vs.<br>30d FU | Post-<br>Tx vs.<br>30d<br>FU |
| Mean±SD | 45.13±<br>13.24 | 92.5±<br>9.69 | 92.6±<br>9.49 | 92.63±<br>9.58 | -0.1±<br>0.69 | -0.13±<br>0.61 | -0.03±<br>0.44 |
| Median | 46 | 91.5 | 91.5 | 91.5 | 0 | -0.5 | 0 |
| (Min- Max) | (27-65) | (74.5-107) | (75-107.5) | (75-107.5) | (-1-1.5) | (-0.5-1.5) | (-1 - 0.5) |

Conclusions: The 8 twice-a-week treatments with BTL-9000 at maximum power produce reliable reduction in waist circumference. There was statistically significant difference between the Treatment and Placebo Groups in change in waist circumference from pre- to post-treatment, from pre-treatment to 30-day follow up, from port-treatment to 30-day follow up.

#### I X. Substantial Equivalence

The BTL-9000 is substantially equivalent to its predicate device when used according to its intended use. This is based on the information provided in this 510(k) Premarket Notification which demonstrates that the BTL-9000 shares the same technological characteristics, mechanism of action, intended use and physical properties when compared to its predicates.

#### X. Conclusion

Based on similar intended use, technological characteristics, and technical and clinical performance characteristics, the BTL-9000 is substantially equivalent to its respective predicate device.

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Confidential