UltraClear Fractional Laser System

K210847 · Fa International, LP · GEX · Dec 10, 2021 · General, Plastic Surgery

Device Facts

• Record ID: K210847
• Device Name: UltraClear Fractional Laser System
• Applicant: Fa International, LP
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Dec 10, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The UltraClear Laser System is intended for use in Dermatology and Plastic Surgery applications for the following indications for use: General skin resurfacing procedures. Ultra mode is further indicated for the following fractional applications: Treatment of wrinkles; Epidermal nevi; Telangiectasia; Spider veins; Actinic chelitis; Keloids; Verrucae; Skin tags; Anal tags; Keratoses; Scar revision (including acne scars).

Device Story

UltraClear Laser System is a transportable 2,910 nm fiber laser for dermatology and plastic surgery. System uses fiber-coupled laser diode assembly to pump erbium-doped fluoride glass fiber; delivers energy via handpiece to water-based chromophores in skin. Includes 15-inch touchscreen, foot pedal, emergency stop, and 635 nm red aiming beam. Operated by clinicians in clinical settings. Provides fractional skin resurfacing and treatment of various dermatological lesions. Output energy is monitored and displayed to the user. Device benefits patients by enabling precise tissue ablation and coagulation for aesthetic and therapeutic skin procedures. System includes internal water/air cooling, scanner drivers, and software controls.

Clinical Evidence

Bench testing only. Performance data included functional specification testing, software verification and validation, and electrical safety/EMC testing per IEC 60601-1, 60601-1-2, 60601-2-22, and 60825-1. A histology study was conducted on human biopsies from three participants to evaluate thermal damage and tissue effects of the laser.

Technological Characteristics

Fiber laser system, 2910 nm wavelength. Er:YAG laser medium. Fiber optic delivery with handpiece. Water and air cooling. 100-240 VAC power. 15-inch touchscreen GUI. Standards: IEC 60601-1 (safety), IEC 60601-1-2 (EMC), IEC 60601-2-22 (laser safety), IEC 60825-1 (laser classification).

Indications for Use

Indicated for dermatology and plastic surgery patients requiring general skin resurfacing or fractional treatment of wrinkles, epidermal nevi, telangiectasia, spider veins, actinic chelitis, keloids, verrucae, skin tags, anal tags, keratoses, and scar revision (including acne scars).

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

• Joule ProFractional System (K180508)

Reference Devices

• CO2RE System (K181523)

Submission Summary (Full Text)

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December 10, 2021

FA International, LP % Sharon Timberlake Regulatory Consultant Sharon Timberlake Consulting, LLC 27 Dunelm Road Bedford, Massachusetts 01730

Re: K210847

Trade/Device Name: UltraClear 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: May 9, 2021 Received: May 11, 2021

Dear Sharon Timberlake:

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. Although this letter refers to your product as a device, please be aware 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.

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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 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/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-

combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Purva Pandya Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known)

K210847

Device Name UltraClear Laser System

#### Indications for Use (Describe)

The UltraClear Laser System is intended for use in Dermatology and Plastic Surgery applications for the following indications for use:

General skin resurfacing procedures

Ultra mode is further indicated for the following fractions: Treatment of wrinkles; Epidermal nevi; Telangiectasia; Spider veins; Actinic chelitis; Keloids; Verrucae; Skin tags; Keratoses; Scar revision (including acne scars).

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
| Prescription Use (Part 21 CFR 801 Subpart D) | |
| Over-The-Counter Use (21 CFR 801 Subpart C) | |

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# K210847

# 510(k) Summary

# UltraClear Laser System

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 807.92.

| Owner/Applicant: | FA International, LP<br>614 George Washington Highway<br>Lincoln, RI 02865<br>[phone] | |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Official Correspondent | Sharon Timberlake Consulting, LLC<br>Sharon Timberlake, MSHS, RAC, CCRA<br>27 Dunelm Road<br>Bedford, MA 01730<br>[phone] | |
| Date of Summary: | December 8, 2021 | |
| Device Trade Name: | UltraClear Laser System | |
| Common/Usual Name: | 2910 nm laser system | |
| Regulation Number: | 21 CFR 878.4810 | |
| Device Class: | II | |
| Product Code: | GEX/ONG | |
| Panel: | General and Plastic Surgery | |
| Predicate Devices | Joule ProFractional System (K180508) | |
| Reference Device | CO2RE System (K181523) | |
| Device Description: | UltraClear Laser System is a transportable device. The system<br>includes the 15" touch screen, on/off switch, foot peddle, an<br>emergency stop button, remote interlock, and calibration port.<br><br>The device console houses most of the power consuming<br>components, including the laser module, medical grade power<br>supply, the scanner drivers, software, TEC cooling module, water<br>pump, fans, software controls, and all other electrical control<br>components.<br><br>The laser system is a fiber laser device operating at a wavelength of<br>2,910nm. The system incorporates a fiber couple laser diode<br>assembly pumping erbium doped fluoride glass fiber to generate<br>laser emission. The laser energy is delivered during treatment via<br>the handpiece. A 635 nm visible red laser diode aiming beam is<br>used to visualize the location of the beam during laser treatment. | |
| Indications for Use: | The UltraClear Laser System is intended for use in Dermatology and Plastic Surgery applications for the following indications for use: General skin resurfacing procedures. Ultra mode is further indicated for the following fractional applications: Treatment of wrinkles; Epidermal nevi; Telangiectasia; Spider veins; Actinic chelitis; Keloids; Verrucae; Skin tags; Anal tags; Keratoses; Scar revision (including acne scars). | |

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## Predicate Comparison Table

| Specifications | UltraClear<br>Fractional Laser<br>System | JOULE ProFractional<br>System | Substantial<br>Equivalence<br>Assessment |
|--------------------------------|----------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|------------------------------------------|
| Manufacturer | FA International | Sciton, Inc. | Not Applicable |
| K Number | K210847 | K180508 | Not Applicable |
| Product Code | GEX, ONG | GEX, ONG | Same |
| Prescription Use | Yes | Yes | Same |
| Laser Energy Source | Er: YAG | Er: YAG | Same |
| Laser Delivery | Fiber & Handpiece | Fiber, Handpiece,<br>Articulated arm | Substantially<br>equivalent |
| Wavelength | 2910 nm | 2940 nm | Substantially<br>equivalent |
| Aiming Beam | Red diode laser<br>5mW | Red diode laser<br>5mW | Same |
| Target<br>Chromophore | Water | Water | Same |
| Fractional<br>Technology | Yes | Yes | Same |
| Energy per<br>Microbeam(mJ/mb) | 0.6-1.5 (Clear Mode)<br>1.5-3.0 (Silk Mode)<br>3.6-35.0 (Ultra Mode)<br>0.6-1.5, 3.6-35.0<br>(UltraClear-Mode) | Up to 70 | Similar, within<br>range |
| Adjustable<br>Spot Size | 2x2mm - 15x15mm | 1.3x1.3mm - 20x20mm | Substantially<br>equivalent |
| Pulse/Repetition<br>Rate | Up to 3 Hz | Up to 3 Hz | Same |
| Pulse<br>Width/Duration | 0.1 to 3.0 msec (or<br>3000 usec) | 0.5 to 1.5 msec (or<br>1500 usec) | Substantially<br>equivalent |
| Delivery System | Fiber optic arm with<br>handpiece | Articulated arm and/or<br>fiber optic arm with<br>handpiece | Same |
| Cooling System | Water & Air | Water & Air | Same |
| Electrical<br>Requirements | 100-240 VAC/8.5A,<br>50/60 Hz | 230 VAC/25A, 50/60<br>Hz | Substantially<br>equivalent |
| Software/GUI/<br>Touch Screen | Yes | Yes | Same |
| Energy Monitor | Display Indicates<br>Energy Delivered to<br>Tissue | Display Indicates<br>Energy Delivered to<br>Tissue | Same |
| Console Dimensions | w15.9" x d20.5" x<br>h42.1" | w14" x d21" x h41" | Substantially<br>equivalent |
| Weight | 80 Lbs | 200 Lbs | Substantially<br>equivalent |
| Power Supply | Yes | Yes | Same |

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## Technological Characteristics / Substantial Equivalence

The UltraClear Laser System is substantially equivalent in design, function, operating principles, and intended use to the Joule ProFractional System (K180508) predicate device based on the information presented. The devices share the same design and technical features, which includes calibration port, handpiece, similar wavelength, laser medium, fiber delivery, power supply, internal cooling system, hardware, electronics, firmware, software and user display screen.

Both the new device and predicate device share the same laser operating principles, such as energy, pulse width, repetition rate, energy delivery and offers a range of spot sizes. Any minor design differences do not raise any new types of safety or effectiveness questions, thus rendering substantial equivalence.

### Performance Data

FA International, LP conducted performance studies to confirm the overall functional specification testing of the UltraClear Laser System against its design specifications and intended use. The following testing was conducted in support substantial equivalence.

### Histology Study

Human biopsies were taken and analyzed post laser treatment. Tissue samples were taken from three participants to establish the thermal damage and tissue effect of lasing.

### Biocompatibility

The patient contacting material of the handpiece are identical to the reference device.

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## Electromagnetic Compatibility & Electrical Safety

UltraClear Laser System underwent electrical safety and electromagnetic compatibility with passing results according to the following recognized standards.

- IEC 60825-1, 2007: Safety of Laser Products – Part 1: Equipment classification and requirements.
- IEC 60601-1, 2005+A1:2012: Medical electrical equipment-- Part 1: General ● requirements for basic safety and essential performance.
- IEC 60601-1-2 Edition 4.0 2014-02: Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests.
- IEC 60601-2-22:2007 + A1: 2012, Edition 3.1: Medical electrical equipment – Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment.

### Software Validation and Verification Testing

UltraClear Laser System underwent software verification and validation testing, which demonstrated the software is appropriate for release and that the system performed as intended. Furthermore, the testing verified the energy outputs of the system meet its design specifications.

### Conclusion

The UltraClear Laser System has the same Intended Use/Indications for Use as the predicate device. The minor differences between the two devices do not raise new or different questions about safety and effectiveness. The performance data presented in this 510(k) Premarket Notification support the safety of the new device. Additionally, the data further supports the new device should perform as intended and to its specifications. In sum, the UltraClear Laser System is as safe and effective as its predicate device.