Multifrax Laser System

K213332 · Paradigm Medical Corporation · ONG · Jun 3, 2022 · General, Plastic Surgery

Device Facts

• Record ID: K213332
• Device Name: Multifrax Laser System
• Applicant: Paradigm Medical Corporation
• Product Code: ONG · General, Plastic Surgery
• Decision Date: Jun 3, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

1550 nm: The Multifrax 1550 nm laser is indicated for use in dermatological procedures requiring coagulation of soft tissue, as well as for skin resurfacing procedures. It is also indicated for treatment of dyschromia and cutaneous lesions, such as, but not limited to lentigos (age spots), solar lentigos (sun spots), actinic keratosis, and melasma, and for treatment of periorbital wrinkles, acne scars and surgical scars. 1927 nm: The Multifrax 1927 nm laser is indicated for use in dermatological procedures requiring the coagulation of soft tissue, treatment of actinic keratosis, and treatment of pigmented lesions such as, but not limited to lentigos (age spots), solar lentigos (sun spots) and ephiledes (freckles).

Device Story

Multifrax Laser System is a portable, non-ablative, fractional diode laser; emits 1550 nm and 1927 nm wavelengths. Device delivers light pulses in rows via handpiece to create micro-thermal zones (MTZ) in skin. Features include adjustable treatment width, adjustable pulse spacing, and integrated movement/skin contact tracking sensors. Operated by healthcare professionals in clinical settings; powered by rechargeable batteries with belt clip. System controlled via color touchscreen. Output allows for precise coagulation and resurfacing; benefits patients through treatment of pigmented lesions, wrinkles, and scars.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included electrical safety (ANSI AAMI ES60601-1), electromagnetic compatibility (IEC 60601-1-2), usability (IEC 60601-1-6), laser safety (IEC 60601-2-22, IEC 60825-1), software validation (IEC 62304), and biocompatibility (ISO 10993-5, -10, -23).

Technological Characteristics

Dual-wavelength (1550/1927 nm) diode laser system. Non-ablative fractional output. Features: adjustable treatment width/pulse distance, integrated movement/contact sensors, color touchscreen. Power: 2 rechargeable batteries. Delivery: handpiece with disposable contact tip. Standards: ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-22, IEC 60825-1, IEC 62304, ISO 10993.

Indications for Use

Indicated for dermatological procedures requiring soft tissue coagulation, skin resurfacing, and treatment of dyschromia, cutaneous lesions (lentigos, solar lentigos, actinic keratosis, melasma, ephiledes), periorbital wrinkles, acne scars, and surgical scars. For use by trained healthcare professionals.

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

• Fraxel Dual 1550/1927 Laser System (K130193)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

June 3, 2022

Paradigm Medical Corporation % Maureen O'connell President O'Connell Regulatory Consultants, Inc. 44 Oak Street Stoneham, Massachusetts 02180

Re: K213332

Trade/Device Name: Multifrax 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: ONG Dated: May 6, 2022 Received: May 9, 2022

Dear Maureen O'connell:

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.

{1}------------------------------------------------

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-reportingcombination-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, D.Eng. 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

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known) K213332

Device Name Multifrax Laser System

#### Indications for Use (Describe)

1550 nm: The Multifrax 1550 nm laser is indicated for use in dermatological procedures requiring coagulation of soft tissue, as well as for skin resurfacing procedures. It is also indicated for treatment of dyschromia and cutaneous lesions, such as, but not limited to lentigos (age spots), solar lentigos (sun spots), and melasma, and for treatment of periorbital wrinkles, acne scars and surgical scars.

1927 nm: The Multifrax 1927 mm laser is indicated for use in dermatological procedures requiring the coagulation of soft tissue, treatment of actinic keratosis, and treatment of pigmented lesions such as, but not limited to lentigos (age spots), solar lentigos (sun spots) and ephiledes (freckles).

| 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)

#### 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."

{3}------------------------------------------------

### 510(k) SUMMARY

### Paradigm Medical Corporation Multifrax Laser System K213332

### 510(k) Owner

Paradigm Medical 7371 Los Brazos San Diego, CA 92127

### Submission Correspondent

Maureen O'Connell O'Connell Regulatory Consultants, Inc. 44 Oak Street Stoneham. MA 02180 Phone: [phone]

Date Prepared: June 3, 2022

### Trade Name of Device

Multifrax Laser System

### Common or Usual Name

Powered laser surgical instrument with microbeam/fractional output

#### Classification Name

Laser surgical instrument for use in general and plastic surgery and dermatology; 21 C.F.R. \$878.4810 Class II Product Code: ONG

#### Predicate Device

Solta Medical, Inc. Fraxel Dual 1550/1927 Laser System cleared in K130193

#### Device Description

The Multifrax Laser System provides non-ablative fractional treatment using the 1550 nm and 1927 nm wavelengths. The mode of action is delivering a series of light pulses in a row as the handpiece tip is moved across the skin which leaves a pattern of microdots (Micro Thermal Zone (MTZ)) of irradiated skin.

Multifrax Laser System is a dual-wavelength diode laser system comprising two laser sources emitting at 1550 and 1927 nm and generating fine pulses of energy.

- Multifrax is a non-ablative and non-invasive fractional laser device. ●

{4}------------------------------------------------

- Multifrax is a light portable laser combining a small laser unit and 2 long lasting ● rechargeable batteries equipped with a belt clip.
- Multifrax offers optimized technical characteristics: adjustable treatment width, adjustable ● distance between laser pulses, distal tip with integrated high-performance movement and skin contact tracking sensors, and color touch screen display.

### Indications for Use

1550 nm: The Multifrax 1550 nm laser is indicated for use in dermatological procedures requiring coagulation of soft tissue, as well as for skin resurfacing procedures. It is also indicated for treatment of dyschromia and cutaneous lesions, such as, but not limited to lentigos (age spots), solar lentigos (sun spots), actinic keratosis, and melasma, and for treatment of periorbital wrinkles, acne scars and surgical scars.

1927 nm: The Multifrax 1927 nm laser is indicated for use in dermatological procedures requiring the coagulation of soft tissue. treatment of actinic keratosis, and treatment of pigmented lesions such as, but not limited to lentigos (age spots), solar lentigos (sun spots) and ephiledes (freckles).

### Substantial Equivalence

Paradigm Medical believes that the Multifrax described in this notification and for use under the conditions of the proposed labeling is substantially equivalent to a legally marketed predicate device that is a Class II medical device which is the Fraxel Dual 1550/1927 nm Laser System cleared in K130193. The table below compares the properties of the two devices.

| Characteristic | Multifrax | Fraxel Dual 1550/1927 nm<br>Laser System |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Paradigm Medical | Solta Medical, Inc. |
| 510(k)<br>Number | - | K130193 |
| Product Code | ONG | GEX |
| Regulation | 21 CFR 878.4810 | 21 CFR 878.4810 |
| Indications<br>for Use | 1550 nm: The Multifrax 1550 nm laser<br>is indicated for use in dermatological<br>procedures requiring coagulation of<br>soft tissue, as well as for skin<br>resurfacing procedures. It is also<br>indicated for treatment of dyschromia<br>and cutaneous lesions, such as, but not<br>limited to lentigos (age spots), solar<br>lentigos (sun spots), actinic keratosis,<br>and melasma, and for treatment of<br>periorbital wrinkles, acne scars and<br>surgical scars.<br><br>1927 nm: The Multifrax 1927 nm laser<br>is indicated for use in dermatological<br>procedures requiring the coagulation of<br>soft tissue, treatment of actinic<br>keratosis, and treatment of pigmented<br>lesions such as, but not limited to | 1550: The Fraxel 1550 nm laser is<br>indicated for use in dermatological<br>procedures requiring coagulation of soft<br>tissue, as well as for skin resurfacing<br>procedures. It is also indicated for<br>treatment of dyschromia and cutaneous<br>lesions, such as, but not limited to<br>lentigos (age spots), solar lentigos (sun<br>spots), actinic keratosis, and melasma,<br>and for treatment of periorbital wrinkles,<br>acne scars and surgical scars.<br><br>1927 nm: The Fraxel 1927 nm laser is<br>indicated for use in dermatological<br>procedures requiring the coagulation of<br>soft tissue, treatment of actinic keratosis,<br>and treatment of pigmented lesions such<br>as, but not limited to lentigos (age spots), |

{5}------------------------------------------------

| | lentigos (age spots), solar lentigos (sun spots) and ephiledes (freckles). | solar lentigos (sun spots) and ephiledes (freckles). |
|-------------------------|----------------------------------------------------------------------------|------------------------------------------------------|
| Clearance<br>Type | Prescription | Prescription |
| User | Healthcare Professional | Healthcare Professional |
| Operating<br>Principles | Non-ablative treatment | Non-ablative treatment |
| Laser Source | Laser diode | Erbium fiber<br>Thulium fiber |
| Delivery<br>System | Handpiece | Fiber delivery<br>to Handpiece |
| Laser<br>Wavelength | 1550 nm<br>1927 nm | 1550 nm<br>1927 nm |
| Pulse Energy | 4 to 70 mJ (1550 nm)<br>1 to 20 mJ (1927 nm) | 4 to 70 mJ (1550 nm)<br>5 to 20 mJ (1927 nm) |
| Tissue<br>Contact | Disposable contact tip | Disposable contact tips |
| Power source | 2 rechargeable batteries | Power supply |

The intended use of the Multifrax as well as the indications for use are identical. Both are prescription devices for use by trained healthcare professionals for non-ablative dermatological laser treatment. The devices have the same technological characteristics. Both lasers are 1550 nm and 1927 nm diode lasers. Both are delivered to the patient via a handpiece with a contact tip. The upper pulse energy of both devices is the same for both wavelengths. The scaming shape is a single line for both devices. Neither device has an aiming beam. Both devices are software controlled and operated via a touchscreen.

# Performance Data

Non-clinical testing was performed to verify that the proposed device met all design specifications and is substantially equivalent to the predicate device. Testing was performed to the following standards and the Multifrax Laser System was found to meet the requirements:

- Electrical safety per ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, ● C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)
- . Electromagnetic compatibility per 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 disturbances - Requirements and tests
- Usability per IEC 60601-1-6 2010, AMD 1: 2013 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Usability
- Laser equipment safety per IEC 60601-2-22 Medical electrical equipment Part 2: . Particular requirements for the basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment.
- Laser safety per IEC 60825-1:2014 Safety of laser products-Part 1: Equipment ● classification and requirements

{6}------------------------------------------------

- Software validation and verification per IEC 62304:2006 Medical device software-. Software life cycle processes
- Biocompatibility per ISO 10993-23:2021 Biological evaluation of medical devices-Part . 23: Tests for irritation; ISO 10993-10:2021 Biological evaluation of medical devices-Part 10 :Tests for irritation and skin sensitization; and ISO 10993-5 :2009 Third edition Biological evaluation of medical devices-Part 5 : Tests for in vitro cytotoxicity

## Conclusion

Based on the substantial equivalence discussion and the performance testing, the Multifrax Laser System is substantially equivalent to the Fraxel Dual 1550/1927 nm Laser System.