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.

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

AI/ML Overview

The provided document describes the FDA 510(k) clearance for the Exilite system, an Intense Pulsed Light (IPL) device. The clearance is based on substantial equivalence to a predicate device, not on a clinical study demonstrating the device's performance against specific acceptance criteria. Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets them in the context of diagnostic or AI-powered medical devices.

Instead, the document focuses on:

Indications for Use: Reduction of pigmented lesions, acne therapy, freckle, vascular lesions, facial blemish removal, and permanent reduction in hair regrowth.
Non-clinical Testing: Compliance with electrical safety, risk management, software lifecycle, electromagnetic compatibility, and biological evaluation standards (ISO 14971, IEC 62304, ISO 60601-1, ISO 60601-1-2, ISO 10993-5, ISO 10993-10).
Comparison with a Predicate Device: The Exilite system is compared to the Intense Pulsed Light (IPL) Systems from Beijing KES Biology Technology Co., Ltd. (K122995) based on technical characteristics such as light source, emitted by, operation, wavelength, deliver system, electrical protection, maximal fluence, pulse delay, pulse duration, pulse type, and cooling method.

Therefore, I cannot provide a table of acceptance criteria and reported device performance related to diagnostic accuracy, sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details because this information is not present in the provided 510(k) summary. The substantial equivalence determination was made based on technical characteristics and safety standards rather than a clinical performance study with specific outcome measures.

The document explicitly states: "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."

Summary

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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

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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

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Indications for Use

510(k) Number (if known) K150051

Device Name Exilite

Indications for Use (Describe)

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 DriveFramingham, MA 01702Tel: +1-866-285-1656Fax: +1-888-499-2502
Applicant:	BTL Industries, Inc.47 Loring DriveFramingham, MA 01702Tel: +1-866-285-1656Fax: +1-888-499-2502
Contact Person:	Jan ZarskyBTL Industries, Inc.Executive VP

zarsky@btlnet.com

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 InstrumentWith 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 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 BiologyTechnology Co., Ltd.
510(k)number	Current submission	K122995
Light Source	Intense Pulsed Light	Intense Pulsed Light
Emitted by	Flash lamp	Flash lamp
OperatingConditions	Ambient temperature+15 °C to +30 °C	N/A
	Relative humidity 30% to75%	N/A
	Atmospheric pressure700hPa to 1060hPa	N/A
	Position on castors	N/A
Operation	Touch screen	Touch screen
Wavelength	480 – 1200 nm	430 – 1200 nm
DeliverSystem	Sapphire	Sapphire
Indicationsfor Use	Exilite system (inclusive ofthe handpiece used todeliver pulsed-light energy)is indicated for use insurgical and aestheticapplications in reduction ofpigmented lesions, acnetherapy, freckle, vascularlesions, facial blemishremoval and permanentreduction in hair regrowth,defined as a long-term,stable reduction in thenumber of hairs re-growingwhen measured at 6, 9, and12 months after thecompletion of treatmentregimen.	The Intense PulsedLight (IPL) Systems(inclusive of thehandpiece used todeliver pulsed-lightenergy)are indicated for use insurgical, aesthetic andcosmetic applications inpermanent hairremoval, skinrejuvenation, reductionof pigmented lesions,acne therapy, freckle,vascular lesions andfacial blemish removal.
Device name	Exilite	Intense Pulsed light(IPL) Systems
Manufacturer	BTL Industries Ltd.	Beijing KES BiologyTechnology Co., Ltd.
510(k)number	Current submission	K122995
ElectricalProtection	Class II, BF	Class II, BF
MaximalFluence	10-60J/cm²	10-60J/cm²
Spot Size	11x40mm	12x33mm15x50mm15x35mm
Pulse Delay	1-50ms	5-50 ms
PulseDuration	1-20ms	3-20ms
Pulse Type	Single, multiple	Single, multiple
ElectricalRequirements	100-240 V, 50-60 Hz	220V±20V, 50Hz or110V±20V, 60Hz, 20A
Weight	45.55kg	23kg
DimensionsW x H x D	System console - 580 x 980x 580 mm	440 x 500 x 350 mm
Cooling	Sapphire	Sapphire
CoolingMethod	Continuous contact cooling	Continuous contactcooling
Deviceclasification	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, IEC60601-1-2

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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.

Regulation Number and Section

§ 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.