Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.

Device Description

Intense pulsed light system is a unit for general surgery and in dermatology using intense Pulsed Light system intended to cut, destroy, or remove tissue by light energy emitted by flash lamp. It is a light source with a wavelength range of approximately 530nm~1100nm.

This equipment is composed of the main body and a hand piece which is an irradiation device, and, as an accessory part, protective goggles for protection of the worker.

Operation principle: This equipment is controlled by a micro-processor interfaced to a LCD touch screen control panel. The computer controls start and stop of the treatment and on and off of the equipment. When the key switch of the system is turned clockwise, the main power will be inputted, which will be conveyed to the hand piece through the control board.
Meanwhile, the control board connected to the touch screen is connected to the lamp of the hand piece and controls the same, and controls the whole system through the data connected to the touch screen control panel. When the switch of the hand piece is pressed, the lamp will radiate light, which will be outputted after being filtered to a certain wavelength (530nm~1100nm) by the two filters of the hand piece.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the A-Tone IPL System, seeking substantial equivalence to predicate devices. It does not contain information about acceptance criteria, device performance from a study, sample sizes, expert qualifications, or ground truth establishment for a new study. Instead, it relies on demonstrating substantial equivalence to existing, legally marketed devices.

Therefore, many of the requested details cannot be extracted from the provided document.

Here's a breakdown of what can and cannot be answered:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria: Not explicitly stated as pass/fail criteria for a new clinical study. The device's "acceptance" is based on demonstrating substantial equivalence to predicate devices through technical comparisons and compliance with recognized standards.
Reported Device Performance: No performance metrics from a specific clinical study for the A-Tone IPL system are reported in the document. The filing states "Clinical Performance Data: Not Applicable" and "Non-Clinical Performance Data: Not Applicable" in the context of this submission. The "Performance Data" section primarily lists compliance with voluntary recognized standards (e.g., EN 1041, EN 980, ISO 9001, ISO 13485, ISO 14971, EN 60601-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60601-2-22, IEC 60825-1).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not applicable. The submission states "Clinical Performance Data: Not Applicable," indicating no specific test set or clinical study was conducted for this 510(k) submission to demonstrate performance in terms of efficacy or safety with new data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable. As no specific clinical test set was used, there's no mention of experts establishing a ground truth for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. No clinical test set data is presented.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is an IPL system, not an AI-assisted diagnostic tool. There is no mention of MRMC studies or AI assistance for human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

Not applicable. This device is an IPL system, not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not applicable. No new clinical data or ground truth establishment relevant to a study is discussed. The "ground truth" for the device's substantial equivalence is based on its similarity to legally marketed predicate devices and compliance with established safety and performance standards.

8. The sample size for the training set:

Not applicable. This submission does not describe a machine learning model or a training set.

9. How the ground truth for the training set was established:

Not applicable. This submission does not describe a machine learning model or a training set.

Summary of available information regarding performance and acceptance:

The "Performance Data" section confirms that the A-Tone IPL System:

Complies with recommendations from the FDA guidance document "Guidance on the Content and Organization of a Premarket Notification for a Medical Laser."
Adheres to several voluntary recognized standards, including:
- EN 1041 [1998-02] Information supplied by the manufacturer with medical devices.
- EN 980 [2003] Graphical symbols for use in the labeling of medical devices.
- ISO 9001 (2008-12-15) Quality management systems.
- ISO 13485 [2003-7-15] Medical devices Quality management systems.
- ISO 14971 [2007] Medical devices Application of risk management to medical devices.
- EN 60601-1 Medical Electrical Equipment -- Part 1: General Requirements for Safety; Electromagnetic Compatibility.
- IEC 60601-1-2 [2007] Medical electrical equipment- Part 1-2: General Requirements for Safety -Collateral Standard: Electromagnetic Compatibility.
- IEC 60601-1-4 [2000] Medical electrical equipment- Part 1: General requirements for Safety 4th Collateral standard: Programmable electrical medical systems.
- IEC 60601-2-22 [1996] Medical electrical equipment - Part 2: Particular Requirements for the Safety of Diagnostic and Therapeutic Laser equipment.
- IEC 60825-1 [2007] Safety of laser products Part 1: Equipment classification and requirements.

The submission concluded that "performance testing, including software validation testing, electrical and mechanical safety testing according to EN 60601-1, electromagnetic compatibility testing according to IEC 6060 1-1-2... demonstrated that the minor differences in the device software and specifications meet the system requirements and do not raise new safety or effectiveness concerns." This suggests that compliance with these standards and successful completion of specified performance tests served as the "acceptance criteria" for demonstrating safety and effectiveness in the context of this 510(k) submission, leading to the determination of substantial equivalence.

Summary

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YBK Investment Inc.

KI31712

3. 510(k) Summary

MAY 3 0 2014

Submitter: Yong Kim Meditime by YBK Investment 675 Brea Canyon Rd. Ste.8 Walnut, CA 91789 Tel: 909-274-7700

Official Correspondent:

Joyce Bang Provision Consulting Group 1915 White Star Dr. Diamond Bar, CA 91765 Tel: 909-680-8562 Fax: 909-274-7086

Device Information

Trade Name: A-Tone IPL System Common Name: Powered Light Based Non-Laser Surgical Instrument With Thermal Effect Classification Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Product Code: ONF Regulation Number: 21 CFR Part 878.4810 Device Class: Class II Date of submission: 6/3/2013

General Description

This equipment is composed of the main body and a hand piece which is an irradiation device, and, as an accessory part, protective goggles for protection of the worker.

Operation principle: This equipment is controlled by a micro-processor interfaced to a LCD touch screen control panel. The computer controls start and stop of the treatment and on and off of the equipment. When the key switch of the system is turned clockwise, the main power will be inputted, which will be conveyed to the hand piece through the control board.
Meanwhile, the control board connected to the touch screen is connected to the lamp of the hand piece and controls the same, and controls the whole system through the data connected to the touch screen control panel. When the switch of the hand piece is pressed, the lamp will radiate light, which will be outputted after being filtered to a certain wavelength (530nm~1100nm) by the two filters of the hand piece.

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Indication for Use

A-tone systems are indicated for permanent hair reduction, and the treatment of benign vascular and pigmented lesions.

Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.

Predicate Devices:

The subject device is substantially equivalent to the following predicate devices:

StarLuxTM Pulsed Light System (K041086) .
Intense Pulsed Light (IPL) Systems (K122995) .

Comparison to Predicate Devices:

The A-Tone has a substantially equivalent intended use as the identified predicates, StarLuxTM Pulsed Light System (K041086), Intense Pulsed Light (IPL) Systems (K122995). The A-Tone IPL System is Intense pulsed light system is a unit for general surgery and in dermatology using intense Pulsed Light system intended to cut, destroy, or remove tissue by light energy emitted by flash lamp. It is a light source with a wavelength range of approximately 530nm~1100nm. The system is same or similar to other commercially available products based on the light source, intended use, applications, the claims, the spectrum and functioning characteristics.

The A-Tone IPL system, StarLuxTM Pulsed Light System (K041086), Intense Pulsed Light (IPL) Systems (K122995) are similar in fundamental scientific technology. These predicate devices and A-tone IPL System have been designed, manufactured and tested in compliance with FDA's Class II special controls guidance document Guidance on the Content and Organization of a Premarket Notification for a Medical Laser

Performance Data:

All of the data consistent with the recommendations in the FDA guidance document Guidance on the Content and Organization of a Premarket Notification for a Medical Laser. The A-Tone IPL System has been tested and complies with the following voluntary recognized standards:

EN 1041 [1998-02] Information supplied by the manufacturer with medical devices .
EN 980 [2003] Graphical symbols for use in the labeling of medical devices .
ISO 9001 (2008-12-15) Quality management systems .
ISO 13485 [2003-7-15] Medical devices Quality management systems .
ISO 14971 [2007] Medical devices Application of risk management to medical devices .
EN 60601-1 Medical Electrical Equipment -- Part 1: General Requirements for Safety; . Electromagnetic Compatibility
. IEC 60601-1-2 [2007] Medical electrical equipment- Part 1-2: General Requirements for Safety -Collateral Standard: Electromagnetic Compatibility
. IEC 60601-1-4 [2000] Medical electrical equipment- Part 1: General requirements for Safety 4th Collateral standard: Programmable electrical medical systems
. IEC 60601-2-22 [1996] Medical electrical equipment - Part 2: Particular Requirements for the Safety of Diagnostic and Therapeutic Laser equipment

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IEC 60825-1 [2007] Safety of laser products Part 1: Equipment classification and requirements .
Non-Clinical Performance Data: Not Applicable

Clinical Performance Data: Not Applicable

Substantial Equivalence Comparison chart

Product name	A-Tone	StarLuxTM Pulsed Lightsystem	Intense Pulsed Light (IPL)Systems
Manufacturer	AMT ENGINEERING CO.,LTD	PALOMAR MEDICALPRODUCTS, INC	Beijing KES BiologyTechnology Co., Ltd.
510(k) number	current submission	K041086	K122995
Light source	Intense Pulsed Light	Intense Pulsed Light	Intense Pulsed Light
emitted by	flash lamp	flash lamp	flash lamp
accessories	Hand piece, foot switch,goggles	Hand piece, foot switch,goggles	Hand piece, foot switch,goggles
Operation	touch screen	touch screen	touch screen
Intended use	A-tone system is intendeduse for permanent hairreduction, and thetreatment of benignvascular and pigmentedlesions.Permanent hair reduction isdefined as the long-term,stable reduction in thenumber of hairs regrowingwhen measured at 6, 9, and12 months after thecompletion of a treatmentregime.	The StarLuxTM System isintended for treatment ofinflammatory acne andfor the treatment ofcutaneous lesions,including warts, scars andstriae.	The Intense Pulsed Light (IPL)Systems (inclusive of thehandpiece used to deliverpulsed-light energy) areindicated for use in surgical,aesthetic and cosmeticapplications in permanenthair removal, skinrejuvenation, reduction ofpigmented lesions, acnetherapy, freckle, vascularlesions and facial blemishremoval.
Energy spectrum	530nm-1100nm	400-1200nm	430nm~1200nm
Spot size	12 x 38mm	16x46mm, 12x28mm,10 x 15 mm	12mm x 50mm
Fluence	Up to 25J/cm²	Up to 50 J/cm²	Up to 60J/cm²

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Pulse type	Single, multiple	Single	single, multiple
Pulse duration	1-20ms	1-500 ms	1~20ms
Pulse delay	5-60ms	N/A	5~50ms
Repetition rate	1Hz	up to 2Hz	0.2Hz; 2Hz
delivery system	Direct coupling throughcoated filter light guide	Direct coupling throughcoated filter light guide	Direct coupling throughcoated filter light guide
Electrical requirements	AC 230 V, 50 Hz, 9A	100-240 V, 50/60 Hz	220V±20V 50Hz or110V±20V, 60Hz
Cooling method	Continuous contact cooling	Continuous contact cooling	Continuous contact cooling
device classification	II:21 CFR 878.4810	II:21 CFR 878.4810	II:21 CFR 878.4810
Product Code	ONF	GEX	ONF
Delivery system	BK7	Bk7, fused silica, sapphire	Sapphire

Safety and Effectiveness

The A-Tone IPL system and predicate devices are same or similar in light source, range of spectrum, application, and are non-sterilized products. Differences in the specifications between the A-tone IPL system and the predicates do not result in different performance or raise new questions of safety or effectiveness.

The safety features in the A-Tone IPL System are substantially equivalent to the safety features found in the predicate device. Any minor differences in the technological characteristics do not raise new safety or effectiveness concerns. Furthermore, the A-Tone IPL System underwent performance testing, including software validation testing, electrical and mechanical safety testing according to EN 60601-1, electromagnetic compatibility testing according to IEC 6060 1-1-2. These performance tests demonstrated that the minor differences in the device software and specifications meet the system requirements and do not raise new safety or effectiveness concerns. Thus, the A-Tone IPL system should not raise new issues of safety and effectiveness and is judged to be substantially equivalent to the mentioned predicate devices to be legally marketed in the USA.

Conclusions:

Based on the performance testing and comparison to predicate devices, the A-Tone IPL system is substantially equivalent to the predicate device listed above.

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

May 30, 2014

YBK Investment Incorporated % Ms. Joyce Bang Provision Consulting Group 1915 White Star Drive Diamond Bar, California 91765

Re: K131712

Trade/Device Name: A-Tone IPL 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: ONF Dated: May 8, 2014 Received: May 13, 2014

Dear Ms. Bang:

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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Page 2 - Ms. Joyce Bang

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/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/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 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

Binita S. Ashar, M.D., M.B.A., F.A.C.S. for

Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K131712

Device Name A-Tone IPL system

Indications for Use (Describe)

A-tone systems are indicated for permanent hair reatment of benign vascular and pigmented lesions. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.

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.

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

Neil R Ogden -S 2014.05.30 15:03:02 -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 The burden time for the oclices of inting 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."

FORM FDA 3881 (1/14)

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.