A-FIT

K173676 · Hironic Co., Ltd. · GEX · Sep 14, 2018 · General, Plastic Surgery

Device Facts

• Record ID: K173676
• Device Name: A-FIT
• Applicant: Hironic Co., Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Sep 14, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

A-FIT is a dual-modality dermatological system combining a 1450 nm diode laser and a radio frequency (RF) stimulator. The laser component delivers energy to skin tissue to induce incision, destruction, and removal; a cryogen cooling system is integrated into the handpiece to mitigate thermal pain and skin irritation. The RF component delivers high-frequency energy through electrodes to generate heat via contact resistance, promoting coagulation or therapeutic heating. Operated by clinicians in a dermatological setting, the device features a touch-screen interface for parameter setting and a footswitch for activation. The system provides thermal energy for soft tissue management and topical heating for pain relief and circulation. Benefits include precise tissue ablation and non-invasive therapeutic heating.

Clinical Evidence

Bench testing only. No clinical data provided. Performance evaluated via compliance with IEC 60601-1 (safety), IEC 60601-1-2 (EMC), IEC 60825-1 (laser safety), IEC 60601-2-2 (RF equipment), and IEC 60601-2-22 (laser equipment). Biocompatibility verified per ISO 10993-1, -5, and -10. Software verified and validated per IEC 62304.

Technological Characteristics

Dual-modality system: 1450 nm diode laser (±10%) and RF stimulator (550, 700, 1000 kHz). Laser delivery via optical fiber; RF delivery via bipolar electrodes. Includes cryogen cooling system. Interface: Touch LCD. Power: 110V 60Hz. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60825-1, IEC 60601-2-2, IEC 60601-2-22, ISO 14971, ISO 10993, IEC 62304, IEC 62366.

Indications for Use

Indicated for dermatology patients requiring incision, excision, ablation, and vaporization of soft tissue; treatment of back acne, atrophic acne scars, facial wrinkles, mild to moderate acne vulgaris, and sebaceous hyperplasia. RF hand piece indicated for topical heating to treat pain, muscle spasms, and increase local circulation.

Regulatory Classification

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.

Predicate Devices

• CANDELA SMOOTHBEAM LASER SYSTEM (K041242)
• truSculpt (K133739)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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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

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## 5. 510(k) Summary

## 1. General Information

| Applicant/Submitter: | Hironic Co., Ltd. |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 19F, 767, Sinsu-Ro, Suji-Gu<br>Yongin-Si, Gyeonggi-do, 16827<br>Republic of Korea<br>Tel) [phone]<br>Fax) [phone] |
| Contact Person: | Mina Joo, BT Solutions, Inc. |
| Address: | Unit 502, 148 Yuksamro, Gangnam-gu, Seoul,<br>Republic of Korea<br>Tel) +82.2.538.9140<br>Email) [e-mail] |
| 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<br>surgery and in dermatology<br>Electrosurgical cutting and coagulation device and<br>accessories |
| Product Code: | GEX, PBX |
| Regulation Number: | 878.4810<br>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.

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## 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<br>SYSTEM | A-FIT |
| Clearance Date: | April 23, 2004 | N/A |
| Classification /<br>Regulation | Class II / (21 CFR § 878.4810 Laser<br>Surgical Instrument for use in General<br>and Plastic Surgery and in Dermatology) | Class II / (21 CFR § 878.4810 Laser<br>Surgical Instrument for use in General<br>and Plastic Surgery and in Dermatology) |
| Product Code | GEX | GEX |
| Light Source | Diode Laser | Diode Laser |
| Wavelength -<br>Beam radiation | 1450 nm | 1450 nm ± 10% |
| Wavelength -<br>Beam pointing | Unknown | 635 nm ± 10 % |
| Indications for<br>Use / Intended<br>Use | For use in dermatology: incision,<br>excision, ablation, and vaporization with<br>hemostasis of soft tissue,<br>Treatment of back acne<br>Treatment of atrophic acne scars<br>Treatment of facial wrinkles<br>Treatment of mild to moderate acne<br>vulgaris<br>Treatment of Sebaceous Hyperplasia | For use in dermatology: incision,<br>excision, ablation, and vaporization with<br>hemostasis of soft tissue,<br>Treatment of back acne<br>Treatment of atrophic acne scars<br>Treatment of facial wrinkles<br>Treatment of mild to moderate acne<br>vulgaris<br>Treatment of Sebaceous Hyperplasia |
| Intended for | Prescription Use | Prescription Use |
| Maximum Pulse<br>Duration (Pulse<br>Width) | 210 ms | Total 250 ms (62.5 ms X 4) ± 10%<br>Total 250 ms (4.17 ms X 60) ± 10% |
| Maximum laser<br>output (J/cm²) | 8-25 J/cm² | 4 J/cm² - 13 J/cm² ± 20%<br>(Soft and Normal modes) |
| Maximum laser<br>output - Beam<br>pointing | Unknown | < 5 Mw |
| Laser radiation<br>range - Beam<br>radiation | 4mm, 6mm | 6mm ± 20% |
| Laser radiation<br>range - Beam<br>pointing | Unknown | 6mm ± 20% |
| Pulse Repetition<br>Rate (Hz) | 1 Hz | Normal Mode: 4 Hz (62.5ms x 4 pulse)<br>Soft Mode: 60 Hz (4.17ms x 60 pulse) |
| Interface | Touch Screen | Touch Screen |
| Beam Delivery<br>System | Handpiece | Handpiece |
| Laser<br>transmission<br>method | Diode | Optical Fiber |
| Activation | Via Foot switch | Via Footswitch |
| Cooling System | Integrated-Spray Duration Control /<br>Canister Counter | Cryogen Cooling Device |
| | | |
| Electrical<br>Requirements | 115/230 VAC 50/60 Hz | 110 V 60 Hz / 2-1A, 600 VA |
| Weight | 40 lbs (18 kg) | 21.8 lbs (48 kg) |
| Dimension | 17" H x 22" W x 20" D (431.8 x 558.8 x 508 mm) | 350 x 500 x 857 mm |
| Operation time | 10 minutes | 10 minutes |

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## A-FIT 510(k) Summary

#### 2) Predicate device for RF – K133739

| | Predicate Device | Proposed Device |
|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(K) Number | K133739 | N/A |
| Manufacturer | Cutera, Inc. | Hironic Co., Ltd. |
| Device Name | truSculpt | A-FIT |
| Clearance Date: | September 5, 2014 | N/A |
| Classification /<br>Regulation | Class II / (21 CFR § 878.4400<br>Electrosurgical Cutting and Coagulation<br>Device and Accessories) | Class II / (21 CFR § 878.4400<br>Electrosurgical Cutting and Coagulation<br>Device and Accessories) |
| Product Code | PBX | PBX |
| Indications for<br>Use / Intended<br>Use | The truSculpt RF energy is intended to<br>provide topical heating for the purpose of<br>elevating tissue temperature for the<br>treatment of selected medical conditions<br>such as relief of pain, muscle spasms,<br>and increase in local circulation.<br><br>*The truSculpt massage device is<br>intended to provide a temporary<br>reduction in the appearance<br>of cellulite. | The RF Hand piece energy is intended to<br>provide topical heating for the purpose of<br>elevating tissue temperature for the<br>treatment of selected medical conditions<br>such as relief of pain, muscle spasms,<br>and increase in local circulation. |
| Intended for | Prescription Use | Prescription Use |
| Massage | Yes – as a separate handpiece | N/A |
| Treatment<br>activation | Via Finger switch | Via Footswitch |
| Electrode shape | Square or Rectangular | Circle |
| RF frequency | 300 kHz – 50 MHz | 550 kHz, 700 kHz, 1000 kHz |
| RF type | Bipolar/Monopolar | Bipolar |
| Max RF power | Max 300 W | 12 Watt (240 mA, 48.0 Vrms, 200 Ω,<br>RET) |

*A-FIT does not include the massaging device. However, the A-FIT's RF hand piece share the same intended use of the predicate device (truSculpt's RF energy).

#### 4. 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.

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#### A-FIT

#### 510(k) Summary

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.

#### 5. Indications / Intended 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.

## 6. Performance Data

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.

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#### A-FIT

#### 510(k) Summary

- 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.

#### 7. Substantial Equivalence

The intended use of the A-FIT is within the scope of the predicate devices. A-FIT, from both a design and clinical perspective, uses similar or identical technology as the cited predicate devices and has the same intended uses. Based upon the predicted overall performance characteristics for the A-FIT, Hironic Co., Ltd. believes that no significant differences exist in usage of its underlying technological principles between A-FIT and the cited predicate device.

#### 8. Conclusions

On the basis of the information provided in this Summary, A-FIT believes that A-FIT is substantially equivalent to legally commercialized predicate devices for the purposes of this 510 (k) submission.