Fractional CO2 Surgical Laser System

K173359 · Ami, Inc. · GEX · Jul 5, 2018 · General, Plastic Surgery

Device Facts

• Record ID: K173359
• Device Name: Fractional CO2 Surgical Laser System
• Applicant: Ami, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jul 5, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The BIOXEL CO2 Surgical Laser System is indicated for use, in the non-fractionated mode, for Incision, Excision, Ablation, Vaporization, and Coagulation of Human Body Soft Tissues. The system is intended for use in Dermatology, Plastic and General Surgery, Neurosurgery, and Podiatry. The BIOXEL CO2 Surgical Laser System is indicated for use, in the fractionated mode, for Ablative Skin Resurfacing, Wrinkle, Fine line, Rhylides, and Furrows in Dermatology.

Device Story

BIOXEL CO2 Surgical Laser System is a powered laser surgical instrument. It consists of a main body with a touch LCD monitor, an articulated arm, a hand-piece, a foot switch, and a power cable. The device delivers 10,600nm CO2 laser energy to soft tissues. In non-fractionated mode, it performs incision, excision, ablation, vaporization, and coagulation. In fractionated mode, it performs ablative skin resurfacing and treats wrinkles, fine lines, rhytides, and furrows. The system is operated by a clinician in clinical settings. The operator uses the touch screen and monitor to configure parameters and initiates laser output via the foot switch. The device is intended for use in dermatology, plastic and general surgery, neurosurgery, and podiatry.

Clinical Evidence

Bench testing only. Performance data includes software verification and validation, electrical safety and electromagnetic compatibility testing per IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, and IEC 60825-1, and biocompatibility testing of patient-contacting components per ISO 10993-5.

Technological Characteristics

CO2 laser system; 10,600nm wavelength; 40W max power; articulated arm delivery; touch LCD interface; foot switch activation. Electrical safety per IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1. Biocompatibility per ISO 10993-5.

Indications for Use

Indicated for soft tissue incision, excision, ablation, vaporization, and coagulation in dermatology, plastic/general surgery, neurosurgery, and podiatry (non-fractionated mode). Indicated for ablative skin resurfacing and treatment of wrinkles, fine lines, rhytides, and furrows in dermatology (fractionated mode).

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

• MX-7000 MICROXEL (K111831)
• SMAXEL (K180036)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

BraunSolutions % Mr. Alexander Henderson Official Correspondent 970 South Dawson Way Unit 14 Aurora, Colorado 80012-3827

Re: K173359

Trade/Device Name: BIOXEL Fractional CO2 Surgical Laser 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: GEX, ONG Dated: June 1, 2018 Received: June 5, 2018

Dear Mr. Henderson:

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 Actinclude 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 device

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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.

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 medical devices and radiation-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 [phone] or 301-796-7100).

Sincerely.

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) K173359

Device Name BIOXEL CO2 Surgical Laser System

#### Indications for Use (Describe)

The BIOXEL CO2 Surgical Laser System is indicated for use, in the non-fractionated mode, for Incision, Excision, Ablation, Vaporization, and Coagulation of Human Body Soft Tissues. The system is intended for use in Dermatology, Plastic and General Surgery, Neurosurgery, and Podiatry.

The BIOXEL CO2 Surgical Laser System is indicated for use, in the fractionated mode, for Ablative Skin Resurfacing, Wrinkle, Fine line, Rhylides, and Furrows in Dermatology.

Type of Use (Select one or both, as applicable)

| <label><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> |
|-------------------------------------------------------------------------------------------------|
| <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |

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RM. 1412, SJ TECHNO VILLE, 278, BEOTKKOT-RO, GEUMCHEON-GU, SEOUL, KOREA

TEL : [phone] FAX : [phone] E-MAIL : [e-mail]

# EXECUTIVE SUMMARY

#### 1. Name of Device

Trade/Device Name: BIOXEL Fractional CO2 Surgical Laser System Regulation Number: 21CFR 878.4810 Regulation Name: Powered Laser Surgical Instrument Regulation Description: Laser Surgical instrument for use in general and plastic surgery and dermatology. Device Class: II Product Code: GEX

#### 2. Predicate Devices

K111831 MX-7000 MICROXEL, Dae Shin Enterprises K180036 SMAXEL, IDS, Ltd.

### 3. Prior Submissions Statement

There were no prior submissions for the BIOXEL Fractional CO2 Surgical Laser System.

### 4. Device Description

The BIOXEL CO2 Surgical Laser System is used in Dermatology, Plastic and General Surgery, Neurosurgery and Podiatry.

This equipment consists of main body, Articulated Arm, hand-piece, protective goggles, foot switch and power cable. In a main body, there are a monitor displaying all information needed by an operator at a glance and a touch LCD screen, which facilitates operation of this equipment at user's convenience. The laser output is initiated with the foot switch.

#### 5. Indications for Use

The BIOXEL CO2 Surgical Laser System is indicated for use, in the non-fractional mode, for Incision, Excision, Ablation, Vaporization, and Coagulation of Human Body Soft Tissues. The system is intended for use in Dermatology, Plastic and General Surgery, Neurosurgery and Podiatry.

The BIOXEL CO2 Surgical Laser System is indicated for use, in the fractional mode, for Ablative Skin Resurfacing, Wrinkle, Fine line, Rhylides, and Furrows in Dermatology.

#### 6. Comparison Chart to Predicate Devices

| Characteristics | BIOXEL (AMI, Inc.)<br>Subject Device | SMAXEL (IDS, Ltd.)<br>K180036 | MICROXEL (Dae Shin)<br>K111831 |
|--------------------------|--------------------------------------|------------------------------------|------------------------------------|
| Laser Wavelength | 10,600nm | 10,600nm | 10,600nm |
| Laser Type | CO2 | CO2 | CO2 |
| Maximum Power | 40W | 40W | 40W |
| Laser Transfer<br>Method | Articulated Arm with hand<br>piece | Articulated Arm with<br>hand piece | Articulated Arm with<br>hand piece |
| Dimensions(mm) | 440 x 480 x 1,830 | 420 x 410 x 920 | 420 x 410 x 1,120 |
| Weight | 50 kgs | 50 kgs | 45 kgs |
| Energy | 1-30 mJ | 5-30 mJ | 4-30 mJ |

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### RM. 1412, SJ TECHNO VILLE, 278, BEOTKKOT-RO, GEUMCHEON-GU, SEOUL, KOREA

TEL : [phone] FAX : [phone] E-MAIL : [e-mail]

| Density | 1-23 Level | 1-23 Level | 1-23 Level |
|------------|----------------------------------------------------------------------------|-----------------------------------------------------------------|--------------------------------------------------------------------------------|
| Scan Size | 20 x 20 mm | 20 x 20 mm | 5 x 15 mm |
| Scan Shape | Square, Hexagonal,<br>Triangular, Circular | Square, Hexagonal,<br>Triangular, Circular | Square, Circle |
| Mode | Fractional Mode<br>General (CW, Normal Pulse,<br>Super Pulse, Ultra Pulse) | General, Fractional, Non-<br>Factional, Low Power<br>Fractional | Fractional Mode<br>Normal Mode(CW, Super<br>Dream Pulse, Ultra<br>Dream Pulse) |
| Off Time | 0.2 ~ 2.5 sec, Single | 0.5 ~ 2.5 sec, Single | 0.5 ~ 1.5 sec, Single |

#### 8. Summary of Performance Testing

The BIOXEL performs as intended based on performance data provided in the submission.

Software: Verification and validation testing of the software confirm that the software version is appropriate for release.

Electrical Safety and Electromagnetic Compatibility: The BIOXEL has been tested for electromagnetic compatibility and electrical safety per the applicable recognized consensus standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22 and IEC 60825-1).

Biocompatibility: Biocompatibility of the patient contacting components of the device has been established per ISO 10993-5.

#### 9. Conclusion

The BIOXEL CO2 Surgical Laser System was found to be substantially equivalent to the predicate devices.

The BIOXEL CO2 Surgical Laser System shares the same or similar indications for use, similar design features, and functional features with, and thus is substantially equivalent to the predicate devices.