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).

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.
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.

AI/ML Overview

The provided text describes the "Multifrax Laser System" and demonstrates its substantial equivalence to a predicate device, the "Fraxel Dual 1550/1927 nm Laser System," through non-clinical performance testing. However, it does not include any studies involving human subjects or AI algorithms. Therefore, I cannot provide information on acceptance criteria and device performance based on a study, sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or ground truth for training/test sets.

The document focuses on non-clinical testing to demonstrate safety and performance against established standards, not on clinical efficacy or comparative effectiveness with or without AI.

Here's a breakdown of what is available in the document regarding performance:

1. A table of acceptance criteria and the reported device performance

The document lists various non-clinical performance standards and states that the "Multifrax Laser System was found to meet the requirements." It doesn't provide specific quantitative acceptance criteria or detailed numerical performance metrics for each standard within the text. Instead, it refers to compliance with the standards themselves.

Acceptance Criteria (Standard)	Reported Device Performance
Electrical safety per ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012	Met requirements
Electromagnetic compatibility per IEC 60601-1-2 Edition 4.0 2014-02	Met requirements
Usability per IEC 60601-1-6 2010, AMD 1: 2013	Met requirements
Laser equipment safety per IEC 60601-2-22	Met requirements
Laser safety per IEC 60825-1:2014	Met requirements
Software validation and verification per IEC 62304:2006	Met requirements
Biocompatibility per ISO 10993-23:2021, ISO 10993-10:2021, and ISO 10993-5:2009	Met requirements

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document as the testing described is non-clinical (i.e., not performed on human subjects).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable as the document describes non-clinical testing against engineering and safety standards, not clinical ground truth establishment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable as the document describes non-clinical testing.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable as the document does not describe any clinical studies, MRMC studies, or AI components.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable as the device is a laser system, not an algorithm, and the document describes non-clinical performance evaluation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not applicable as the document describes non-clinical testing against engineering and safety standards, not clinical ground truth.

8. The sample size for the training set

This information is not applicable as the device is a laser system, not an AI algorithm requiring a training set.

9. How the ground truth for the training set was established

This information is not applicable as the device is a laser system, not an AI algorithm.

Summary

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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.

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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-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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

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Indications for Use

510(k) Number (if known) K213332

Device Name Multifrax Laser System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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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: 978-207-1245

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

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. ●

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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 nmLaser System
Manufacturer	Paradigm Medical	Solta Medical, Inc.
510(k)Number	-	K130193
Product Code	ONG	GEX
Regulation	21 CFR 878.4810	21 CFR 878.4810
Indicationsfor Use	1550 nm: The Multifrax 1550 nm laseris indicated for use in dermatologicalprocedures requiring coagulation ofsoft tissue, as well as for skinresurfacing procedures. It is alsoindicated for treatment of dyschromiaand cutaneous lesions, such as, but notlimited to lentigos (age spots), solarlentigos (sun spots), actinic keratosis,and melasma, and for treatment ofperiorbital wrinkles, acne scars andsurgical scars.1927 nm: The Multifrax 1927 nm laseris indicated for use in dermatologicalprocedures requiring the coagulation ofsoft tissue, treatment of actinickeratosis, and treatment of pigmentedlesions such as, but not limited to	1550: The Fraxel 1550 nm laser isindicated for use in dermatologicalprocedures requiring coagulation of softtissue, as well as for skin resurfacingprocedures. It is also indicated fortreatment of dyschromia and cutaneouslesions, such as, but not limited tolentigos (age spots), solar lentigos (sunspots), actinic keratosis, and melasma,and for treatment of periorbital wrinkles,acne scars and surgical scars.1927 nm: The Fraxel 1927 nm laser isindicated for use in dermatologicalprocedures requiring the coagulation ofsoft tissue, treatment of actinic keratosis,and treatment of pigmented lesions suchas, but not limited to lentigos (age spots),

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	lentigos (age spots), solar lentigos (sun spots) and ephiledes (freckles).	solar lentigos (sun spots) and ephiledes (freckles).
ClearanceType	Prescription	Prescription
User	Healthcare Professional	Healthcare Professional
OperatingPrinciples	Non-ablative treatment	Non-ablative treatment
Laser Source	Laser diode	Erbium fiberThulium fiber
DeliverySystem	Handpiece	Fiber deliveryto Handpiece
LaserWavelength	1550 nm1927 nm	1550 nm1927 nm
Pulse Energy	4 to 70 mJ (1550 nm)1 to 20 mJ (1927 nm)	4 to 70 mJ (1550 nm)5 to 20 mJ (1927 nm)
TissueContact	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

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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.

Regulation Number and Section

§ 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.