(253 days)
Not Found
No
The summary describes a low-level laser system with a control unit and applicator, focusing on the physical mechanism of action (laser penetration and fat cell disruption). There is no mention of AI, ML, image processing, or any data-driven algorithms for analysis or control.
No
The device is used for non-invasive aesthetic use for temporary reduction of waist circumference, which is not considered a therapeutic function.
No
The device is described as a low level laser system for non-invasive temporary reduction of waist circumference by disrupting adipocyte cells, indicating a therapeutic or aesthetic use rather than a diagnostic one.
No
The device description clearly states it consists of a control unit, connection lead, and a Laser Applicator containing laser-emitting diodes, indicating it is a hardware device with software control, not a software-only device.
Based on the provided information, the BTL-9000 device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- BTL-9000 Function: The BTL-9000 is a low-level laser system that is applied directly to the skin to non-invasively reduce waist circumference. It works by affecting fat cells within the body, not by analyzing samples taken from the body.
The description clearly indicates a non-invasive, external application for aesthetic purposes, which is not the function of an IVD.
N/A
Intended Use / Indications for 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.
Product codes
OLI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
waist
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.5400 Low level laser system for aesthetic use
(a)
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.(b)
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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol. The logo is black and white.
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
2
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Neil R Ogden -S 2014.09.09 16:06:09 -04'00
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
SECTION 5: 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
As required by section 807.92(c)
I. General Information
| Submitter: | BTL Industries, Ltd
30 Peshtersko Shouse Blvd
Plovdiv 4002, Bulgaria
Tel: +359 32 622 252
Fax: +359 32 307 890 |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Michail M. Pankratov, MD, PhD
MMP Medical Associates, LLC
16 Appleton Street
Waltham, MA 02453
clregconsult@aol.com
Tel: 617-480-4543
Fax: 781-207-4676 |
| 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 |
| 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
Laser System |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company
name | BTL Industries, Ltd. | Laser Lipo, Ltd. |
| 510(k)
reference | K134040 | K130341 |
| Device
description | Device consists of an electrically
powered control unit using
touchscreen interface. The system
can operate using laser applicator
that is connected to the control
unit. A laser applicator is a device
containing 4 cold laser red laser
emitting diodes. | Device consists of an electrically
powered control unit using
touchscreen interface. The system can
operate using 4, 6, 8 or 10 paddles
that are connected to the control unit.
A paddle is a device containing 6 cold
red laser emitting diodes. |
| Class | II | II |
| Product Code | OLI | OLI |
| Indications for
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. | Strawberry & Cream Low Level Laser
System 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. |
| Mechanism
of
Action | Disruption of adipocyte cells within
the fat layer for the release of fat
and lipids from these cells for non-
invasive aesthetic use. | Disruption of adipocyte cells within the
fat layer for the release of fat and
lipids from these cells for non-invasive
aesthetic use. |
| Power | 200 mW per applicator | 240 mW per paddle |
| Dimensions
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
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
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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
Circumference (cm) | | |
|---------|-----------------|--------------------------|-----------------|-----------------|---------------------------------------|----------------------------|--------------------------|
| | Age | Pre-Tx | Post-Tx | 30-day
FU | Pre-Tx
vs.
Post-Tx | Pre-Tx
vs.
30d
FU | Post-Tx vs.
30d
FU |
| Mean±SD | 44.73±
11.39 | 91.37±
13.14 | 89.23±
12.95 | 87.83±
13.14 | 2.13±
0.61 | 3.53±
0.40 | 1.40±
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
(cm) | | | Change in Waist
Circumference (cm) | | |
|------------|-----------------|-----------------------------|---------------|----------------|---------------------------------------|-------------------------|------------------------------|
| | Age | Pre-Tx | Post-
Tx | 30-day
FU | Pre-Tx
vs.
Post-Tx | Pre-Tx
vs.
30d FU | Post-
Tx vs.
30d
FU |
| Mean±SD | 45.13±
13.24 | 92.5±
9.69 | 92.6±
9.49 | 92.63±
9.58 | -0.1±
0.69 | -0.13±
0.61 | -0.03±
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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