(288 days)
Not Found
No
The document describes a laser and RF energy device with user-controlled parameters and standard safety/performance testing, with no mention of AI or ML.
Yes
The device is intended for various medical conditions such as the treatment of acne, acne scars, facial wrinkles, sebaceous hyperplasia, relief of pain, muscle spasms, and increase in local circulation, which classify it as a therapeutic device.
No
The device description and intended use clearly state that this device is used for treatment purposes (incision, excision, ablation, vaporization, topical heating for pain relief, etc.), not for diagnosing conditions.
No
The device description explicitly states that A-FIT consists of a Laser diode and high-frequency (RF) stimulator, which are hardware components. It also describes a power unit, hand piece, touch LCD, and foot switch, all of which are physical parts of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended uses listed are for direct treatment of skin conditions (incision, excision, ablation, vaporization, acne treatment, wrinkle treatment, pain relief, muscle spasms, increased local circulation). These are all therapeutic applications performed directly on the patient's body.
- Device Description: The device description details a laser and RF stimulator that apply energy directly to the skin tissue for therapeutic effects.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze samples and provide diagnostic information. This device is used in vivo (on the body) for therapeutic purposes.
N/A
Intended Use / Indications for Use
Main Hand Piece
For use in dermatology: incision, excision, ablation, and vaporization with hemostasis of soft tissue,
Treatment of back acne Treatment of atrophic acne scars Treatment of facial wrinkles Treatment of mild to moderate acne vulgaris Treatment of Sebaceous Hyperplasia
Radio Frequency Hand piece
The RF Hand piece energy is intended to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as relief of pain, muscle spasms, and increase in local circulation.
Product codes (comma separated list FDA assigned to the subject device)
GEX, PBX
Device Description
A-FIT consists of Laser diode and high-frequency (RF) stimulator. It can be used for incision, destruction and removal of skin tissue by illuminating a 1450 nm wavelength laser on the skin tissue. In addition, the RF energy can be used to relieve pain.
Laser surgical unit, diode: Specifically, a 1450 nm wavelength laser is absorbed into the skin to be transformed into thermal energy, which then induces incision, destruction and removal of skin tissues. Laser is sent out through the power unit equipped inside the Main Body to oscillate the laser diode, and the user uses the touch LCD in the Main Body to set the output parameters while controlling laser radiation through the foot switch. At this point, a coolant is sprayed from the end of the hand piece to protect skin from the heat generated by the radiated laser, resulting in a reduction in skin irritation and pain.
Electrosurgical system, general-purpose: The operating concept of the electrosurgical unit is to let the high frequency (RF) energy flow through the electrodes of the hand piece to use the load or heat generated by contact resistance, resulting in a coagulant activity on the cell tissues.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin
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)
Non-clinical tests: Testing conducted on the A-FIT shows that it refers to the relevant mandatory performance standards for laser products 21 CFR 1040.11. Other performance, such as electromagnetic compliance, etc, were tested using following consensus standards:
- Basic safety and essential performance of the A-FIT was tested and evaluated according to -IEC 60601-1:2005 (Third Edition) + CORR, 1:2006 + CORR, 2:2007 + A1:2012 (or IEC 60601-1:2012 reprint).
- -Effect to the device by electromagnetic disturbances were tested and evaluated according to the FDA-recognized consensus standard, IEC 60601-1-2 Edition 3: 2007-03.
- -Safety of laser products is evaluated according to IEC 60825-1:2014 (Third Edition).
- General Requirements For Basic Safety And Essential Performance Collateral Standard: -Usability was tested and evaluated according to the FDA-recognized consensus standard, IEC 60601-1-6 Edition 3.1 2013-10.
- Particular Requirements for The Basic Safety and Essential Performance of High -Frequency Surgery Equipment And High Frequency Surgical Accessories was tested and evaluated according to IEC 60601-2-2:2009 (Fifth Edition) + C1:2014.
- Particular Requirements for Basic Safety and Essential Performance of Surgical, Cosmetic, -Therapeutic And Diagnostic Laser Equipment was tested and evaluated according to IEC 60601-2-22:2007 (Third Edition) +A1:2012.
- Risk management was recorded by referring to ISO 14971. -
- -The software for A-FIT has been verified and validated based on its moderate level of concern. Software life cycle processes was evaluated according to the FDA-recognized consensus standard, IEC 62304:2006.
- -Application of usability engineering to medical devices was tested and evaluated according to IEC 62366:2007.
- Biocompatibility of A-FIT was documented referred to ISO 10993-1:2009, ISO 10993--5:2009, and 10993-10:2010.
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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below that.
September 14, 2018
HIRONIC Co., Ltd. % Mina Joo Assistant Manager BT Solutions, Inc. Unit 502, 148 Yeoksam-ro Seoul, 06249 Kr
Re: K173676 Trade/Device Name: A-fit 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: GEX Dated: August 9, 2018 Received: August 15, 2018
Dear Mina Joo:
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 mav, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) NOXANING K173676
Device Name A-FIT
Indications for Use (Describe)
Main Hand Piece For use in dermatology: incision, excision, ablation, and vaporization with hemostasis of soft tissue, Treatment of back acne Treatment of atrophic acne scars Treatment of facial wrinkles Treatment of mild to moderate acne vulgaris Treatment of Sebaceous Hyperplasia
Radio Frequency Hand piece
The RF Hand piece energy is intended to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as relief of pain, muscle spasms, and increase in local circulation.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
] Over-The-Counter Use (21 CFR 801 Subpart C)
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below.
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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."
EF
PSC Publishing Services (301) 443-6740
3
5. 510(k) Summary
1. General Information
| Applicant/Submitter: | Hironic Co., Ltd. |
|---|---|
| Address: | 19F, 767, Sinsu-Ro, Suji-Gu |
| Yongin-Si, Gyeonggi-do, 16827 | |
| Republic of Korea | |
| Tel) +82-31-525-7400 | |
| Fax) +82-505-360-4201 | |
| Contact Person: | Mina Joo, BT Solutions, Inc. |
| Address: | Unit 502, 148 Yuksamro, Gangnam-gu, Seoul, |
| Republic of Korea | |
| Tel) +82.2.538.9140 | |
| Email) smanager@btsolutions.co.kr | |
| Preparation Date: | September – 13 – 2018 |
2. Device Name and Code
| Device Trade Name: | A-FIT |
|---|---|
| Common Name: | Laser Surgical Unit |
| Classification Name: | Laser surgical instrument for use in general and plastic |
| surgery and in dermatology | |
| Electrosurgical cutting and coagulation device and | |
| accessories | |
| Product Code: | GEX, PBX |
| Regulation Number: | 878.4810 |
| 878.4400 | |
| Classification: | Class II |
| Review Panel: | General & Plastic Surgery (ODE) |
3. Technical Characteristics in Comparison to Predicate Devices
A-FIT is substantially equivalent to the following legally marketed predicate devices. We identified two predicate devices under product code GEX for Laser hand piece and PBX for RF hand piece respectively.
4
1) Predicate device for Laser – K041242
| Predicate Device | Proposed Device | |
|---|---|---|
| 510(K) Number | K041242 | N/A |
| Manufacturer | CANDELA CORP. | Hironic Co., Ltd. |
| Device Name | CANDELA SMOOTHBEAM LASER | |
| SYSTEM | A-FIT | |
| Clearance Date: | April 23, 2004 | N/A |
| Classification / | ||
| Regulation | Class II / (21 CFR § 878.4810 Laser | |
| Surgical Instrument for use in General | ||
| and Plastic Surgery and in Dermatology) | Class II / (21 CFR § 878.4810 Laser | |
| Surgical Instrument for use in General | ||
| and Plastic Surgery and in Dermatology) | ||
| Product Code | GEX | GEX |
| Light Source | Diode Laser | Diode Laser |
| Wavelength - | ||
| Beam radiation | 1450 nm | 1450 nm ± 10% |
| Wavelength - | ||
| Beam pointing | Unknown | 635 nm ± 10 % |
| Indications for | ||
| Use / Intended | ||
| Use | For use in dermatology: incision, | |
| excision, ablation, and vaporization with | ||
| hemostasis of soft tissue, | ||
| Treatment of back acne | ||
| Treatment of atrophic acne scars | ||
| Treatment of facial wrinkles | ||
| Treatment of mild to moderate acne | ||
| vulgaris | ||
| Treatment of Sebaceous Hyperplasia | For use in dermatology: incision, | |
| excision, ablation, and vaporization with | ||
| hemostasis of soft tissue, | ||
| Treatment of back acne | ||
| Treatment of atrophic acne scars | ||
| Treatment of facial wrinkles | ||
| Treatment of mild to moderate acne | ||
| vulgaris | ||
| Treatment of Sebaceous Hyperplasia | ||
| Intended for | Prescription Use | Prescription Use |
| Maximum Pulse | ||
| Duration (Pulse | ||
| Width) | 210 ms | Total 250 ms (62.5 ms X 4) ± 10% |
| Total 250 ms (4.17 ms X 60) ± 10% | ||
| Maximum laser | ||
| output (J/cm²) | 8-25 J/cm² | 4 J/cm² - 13 J/cm² ± 20% |
| (Soft and Normal modes) | ||
| Maximum laser | ||
| output - Beam | ||
| pointing | Unknown |