(353 days)
Not Found
No
The device description details a microprocessor-controlled system with a touch screen interface for controlling light output. There is no mention of AI, ML, or any learning or adaptive capabilities. The performance studies reference standard compliance and do not indicate any AI/ML evaluation.
Yes
The device's intended uses, "permanent hair reduction" and "treatment of benign vascular and pigmented lesions," are both therapeutic applications aimed at addressing specific medical conditions or aesthetic concerns.
No
Explanation: The "Intended Use / Indications for Use" section states that the device is "indicated for permanent hair reduction, and the treatment of benign vascular and pigmented lesions," which are therapeutic applications, not diagnostic ones. The device description also focuses on how it emits light energy to "cut, destroy, or remove tissue."
No
The device description explicitly states it is an "Intense pulsed light system" composed of a "main body and a hand piece which is an irradiation device," clearly indicating it is a hardware-based medical device that uses light energy.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for permanent hair reduction and the treatment of benign vascular and pigmented lesions. These are therapeutic and cosmetic procedures performed directly on the patient's body.
- Device Description: The device is an intense pulsed light system that applies light energy to tissue. This is an external application of energy for treatment, not a test performed on samples taken from the body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening based on sample analysis
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device operates by directly interacting with the patient's tissue using light energy.
N/A
Intended Use / Indications 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.
Product codes
ONF
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
general surgery and in dermatology
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)
Non-Clinical Performance Data: Not Applicable
Clinical Performance Data: Not Applicable
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
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
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.
1
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:
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
2
- 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 Light
system | Intense Pulsed Light (IPL)
Systems |
|-----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | AMT ENGINEERING CO.,LTD | PALOMAR MEDICAL
PRODUCTS, INC | Beijing KES Biology
Technology 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 intended
use 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. | The StarLuxTM System is
intended for treatment of
inflammatory acne and
for the treatment of
cutaneous lesions,
including warts, scars and
striae. | 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. |
| 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 |
3
| 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 through | ||
| coated filter light guide | Direct coupling through | ||
| coated filter light guide | Direct coupling through | ||
| coated filter light guide | |||
| Electrical requirements | AC 230 V, 50 Hz, 9A | 100-240 V, 50/60 Hz | 220V±20V 50Hz or |
| 110V±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.
4
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
5
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
6
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'
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