(86 days)
Not Found
No
The description focuses on the device's light spectrum, user interface, and control mechanisms, with no mention of AI or ML capabilities.
Yes
The device is intended for "surgical and aesthetic applications in reduction of pigmented lesions, acne therapy, freckle, vascular lesions, facial blemish removal, and permanent reduction in hair regrowth." These applications directly address medical conditions or physical characteristics for a therapeutic outcome. The "Intended Use" section explicitly states "acne therapy."
No
This device is an Intense Pulsed Light (IPL) system indicated for therapeutic procedures in dermatology and aesthetics, such as reduction of pigmented lesions, acne therapy, and hair reduction. It is not described as diagnosing conditions.
No
The device description explicitly lists hardware components such as a control unit, handpiece, and touch screen, indicating it is a physical device that utilizes software for control and user interface.
Based on the provided information, the Exilite system is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is used for surgical and aesthetic applications directly on the patient's body (reduction of pigmented lesions, acne therapy, hair regrowth reduction, etc.). IVD devices are used to examine specimens (like blood, urine, tissue) taken from the body to provide information about a person's health.
- Device Description: The description details a system that delivers pulsed light energy to the patient's skin. This is a therapeutic or aesthetic treatment, not a diagnostic test performed on a sample.
- Input Imaging Modality: While it uses light, it's described as "Intense Pulsed Light" for treatment, not for imaging or analyzing a biological sample.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, using reagents, or providing diagnostic information based on laboratory tests.
The Exilite system is a therapeutic/aesthetic device that uses light energy for direct treatment of dermatological conditions.
N/A
Intended Use / Indications for Use
Exilite system (inclusive of the handpiece used to deliver pulsed-light energy) is indicated for use in surgical and aesthetic applications in reduction of pigmented lesions, acne therapy, freckle, vascular lesions, facial blemish removal, and permanent reduction in hair regrowth, defined as a long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of treatment regimen.
Product codes (comma separated list FDA assigned to the subject device)
ONF
Device Description
The Exilite device is indicated for the primary treatment of dermatologic deficiencies. It is Intense Pulsed Light System which uses a wide spectrum of light from 480 to 1200nm (yellow, green, red and infrared light).
The control unit of the device is fitted with a color touch screen, which significantly facilitates the use of the device. The on-screen information will guide you through the entire therapy by means of easy setting of parameters using touch-screen buttons and knobs/keys on the device. For easier control, the handpiece is equipped with trigger button, enabling to start the application instead of footswitch.
Any therapeutic parameter can be set easily by simple use of the touch-screen buttons. During the entire therapy time the device informs you about the chosen therapy and applied filter, the set fluence and other necessary data.
The Exilite consists of the following main components:
- control unit
- user interface with 8.4" color touch screen .
- handpiece with cooling sapphire crystal and trigger button
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Intense Pulsed Light
Anatomical Site
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The substantial equivalence determination for the Exilite system is not based upon clinical performance testing. The device safety and efficacy was demonstrated by comparison of technical characteristics between the Exilite as compared to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
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.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
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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 circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around it. Inside the circle is a stylized image of three human profiles facing right, with flowing lines that resemble ribbons or waves.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 8, 2015
BTL Industries Incorporated Mr. Jan Zarsky Executive Vice President 47 Loring Drive Framingham, Massachusetts 01702
Re: K150051 Trade/Device Name: Exilite 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: ONF Dated: January 6, 2015 Received: January 12, 2015
Dear Mr. Zarsky:
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 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
1
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 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/Resourcesfor You/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,
Jennifer R. Stevenson -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) K150051
Device Name Exilite
Indications for Use (Describe)
Exilite system (inclusive of the handpiece used to deliver pulsed-light energy) is indicated for use in surgical and aesthetic applications in reduction of pigmented lesions, acne therapy, freckle, vascular lesions, facial blemish removal, and permanent reduction in hair regrowth, defined as a long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of treatment regimen.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows a logo for BTL. The logo consists of three blue diamonds that are interlocked. The letters B, T, and L are written inside each of the diamonds, respectively.
Section 5 - 510(k) Summary
General Information
| Sponsor: | BTL Industries, Inc.
47 Loring Drive
Framingham, MA 01702
Tel: +1-866-285-1656
Fax: +1-888-499-2502 |
|-----------------|-----------------------------------------------------------------------------------------------------------------|
| Applicant: | BTL Industries, Inc.
47 Loring Drive
Framingham, MA 01702
Tel: +1-866-285-1656
Fax: +1-888-499-2502 |
| Contact Person: | Jan Zarsky
BTL Industries, Inc.
Executive VP |
ONF
Summary Preparation 6 January 2015 Date:
Device Names
Product Code:
| Trade/Proprietary Name: | Exilite |
|---|---|
| Common Name: | Intense Pulsed Light (IPL) |
| Primary Classification Name: | Powered Light Based Non-Laser Surgical Instrument |
| With Thermal Effect | |
| Classification Regulation: | 878.4810 |
Legally Marketed Predicate Devices
The Exilite system is an Intense Pulsed Light (IPL) system, and is substantially equivalent to the current product which is already cleared for USA distribution under the following 510(k) Premarket Notification number:
- . Intense Pulsed Light (IPL) Systems - Beijing KES Biology Technology Co., Ltd (K122995)
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Image /page/4/Picture/0 description: The image shows a logo and the words "Product Description" in bold font. The logo consists of three blue diamond shapes that are connected to each other. The letters "BTL" are inside the first diamond shape.
The Exilite device is indicated for the primary treatment of dermatologic deficiencies. It is Intense Pulsed Light System which uses a wide spectrum of light from 480 to 1200nm (yellow, green, red and infrared light).
The control unit of the device is fitted with a color touch screen, which significantly facilitates the use of the device. The on-screen information will guide you through the entire therapy by means of easy setting of parameters using touch-screen buttons and knobs/keys on the device. For easier control, the handpiece is equipped with trigger button, enabling to start the application instead of footswitch.
Any therapeutic parameter can be set easily by simple use of the touch-screen buttons. During the entire therapy time the device informs you about the chosen therapy and applied filter, the set fluence and other necessary data.
The Exilite consists of the following main components:
- . control unit
- user interface with 8.4" color touch screen .
- . handpiece with cooling sapphire crystal and trigger button
Indications for Use
Exilite system (inclusive of the handpiece used to deliver pulsed-light energy) is indicated for use in surgical and aesthetic applications in reduction of pigmented lesions, acne therapy, freckle, vascular lesions, facial blemish removal and permanent reduction in hair regrowth, defined as a long-term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of treatment regimen.
Non-clinical Testing
The Exilite device has been thoroughly evaluated for electrical safety. The Exilite has been found to conform with applicable medical device safety standards. The system complies with the following standards:
ISO 14971 - Medical devices - Application of risk management to medical devices IEC 62304 - Medical Device Software - Software Life Cycle Processes
Medical Electrical Equipment
- General requirements for safety ISO 60601-1
- ISO 60601-1-2 Electromagnetic compatibility-Requirements and Tests
- Biological Evaluation of Medical Devices—Tests for In Vitro toxicity ISO 10993-5
ISO 10993-10 Biological Evaluation of Medical Devices-Test for Irritation and Skin Sensitization
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Image /page/5/Picture/0 description: The image shows the logo for BTL Clinical Testing. The logo consists of three blue diamond shapes, each containing a letter: B, T, and L. Below the logo, the words "Clinical testing" are written in a bold, sans-serif font.
The substantial equivalence determination for the Exilite system is not based upon clinical performance testing. The device safety and efficacy was demonstrated by comparison of technical characteristics between the Exilite as compared to the predicate devices.
Comparison with the Predicate Device
| Device name | Exilite | Intense Pulsed light
(IPL) Systems |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | BTL Industries Ltd. | Beijing KES Biology
Technology Co., Ltd. |
| 510(k)
number | Current submission | K122995 |
| Light Source | Intense Pulsed Light | Intense Pulsed Light |
| Emitted by | Flash lamp | Flash lamp |
| Operating
Conditions | Ambient temperature
+15 °C to +30 °C | N/A |
| | Relative humidity 30% to
75% | N/A |
| | Atmospheric pressure
700hPa to 1060hPa | N/A |
| | Position on castors | N/A |
| Operation | Touch screen | Touch screen |
| Wavelength | 480 – 1200 nm | 430 – 1200 nm |
| Deliver
System | Sapphire | Sapphire |
| Indications
for Use | Exilite system (inclusive of
the handpiece used to
deliver pulsed-light energy)
is indicated for use in
surgical and aesthetic
applications in reduction of
pigmented lesions, acne
therapy, freckle, vascular
lesions, facial blemish
removal and permanent
reduction in hair regrowth,
defined as a long-term,
stable reduction in the
number of hairs re-growing
when measured at 6, 9, and
12 months after the
completion of treatment
regimen. | The Intense Pulsed
Light (IPL) Systems
(inclusive of the
handpiece used to
deliver pulsed-light
energy)
are indicated for use in
surgical, aesthetic and
cosmetic applications in
permanent hair
removal, skin
rejuvenation, reduction
of pigmented lesions,
acne therapy, freckle,
vascular lesions and
facial blemish removal. |
| Device name | Exilite | Intense Pulsed light
(IPL) Systems |
| Manufacturer | BTL Industries Ltd. | Beijing KES Biology
Technology Co., Ltd. |
| 510(k)
number | Current submission | K122995 |
| Electrical
Protection | Class II, BF | Class II, BF |
| Maximal
Fluence | 10-60J/cm² | 10-60J/cm² |
| Spot Size | 11x40mm | 12x33mm
15x50mm
15x35mm |
| Pulse Delay | 1-50ms | 5-50 ms |
| Pulse
Duration | 1-20ms | 3-20ms |
| Pulse Type | Single, multiple | Single, multiple |
| Electrical
Requirements | 100-240 V, 50-60 Hz | 220V±20V, 50Hz or
110V±20V, 60Hz, 20A |
| Weight | 45.55kg | 23kg |
| Dimensions
W x H x D | System console - 580 x 980
x 580 mm | 440 x 500 x 350 mm |
| Cooling | Sapphire | Sapphire |
| Cooling
Method | Continuous contact cooling | Continuous contact
cooling |
| Device
clasification | II: 21 CFR 878.4810 | II: 21 CFR 878.4810 |
| Product Code | ONF | ONF |
| Standards | IEC 60601-1, IEC 60601-1-
2, ISO 10993-5, ISO 10993-
10, ISI 14971, IEC 62304 | IEC 60601-1, IEC
60601-1-2 |
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Image /page/6/Picture/0 description: The image shows a logo with the letters B, T, and L. The letters are inside of three diamond shapes that are connected to each other. The logo is blue and the background is white. The logo is simple and modern.
Substantial Equivalence
Based upon the intended use and technical information provided in this pre-market notification, the Exilite device has been shown to be substantially equivalent to currently marketed predicate devices.
Conclusion
Based on the aforementioned information, the Exilite is safe and effective and substantially equivalent to the identified predicate devices.