The ResurFX module is constructed of: 1565nm fiber laser Scanner and scanner controller Power Supply Cooling unit Treatment handpiece The system may be activated by either handpiece or footswitch trigger.

AI/ML Overview

The provided document describes the Lumenis ResurFX laser module, its intended use, and its substantial equivalence to predicate devices. However, it does not include detailed acceptance criteria or a study proving the device meets specific performance criteria in the way typically expected for an AI/ML device approval (e.g., sensitivity, specificity, or reader study results).

Instead, the submission focuses on:

Bench performance tests: To ensure the device performs its intended use safely and efficiently.
Histological analysis: To align delivered energy with coagulation impact at the skin tissue level.
Substantial Equivalence Argument: The core of the approval is based on the device being substantially equivalent to existing predicate devices (Fraxel, Palomar Lux1540, Palomar Icon Aesthetic System). This means comparing design, materials, technological characteristics, energy envelopes, and indications for use.

Therefore, many of the specific questions about acceptance criteria for an AI/ML algorithm and related study details cannot be answered from this document.

Here's a breakdown of what can be extracted and what cannot:

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

Acceptance Criteria: Not explicitly stated as quantifiable performance metrics (e.g., sensitivity, specificity, accuracy) for an AI/ML algorithm. The acceptance criteria for this device appear to be compliance with safety standards and functional performance as demonstrated through bench testing and histological analysis, and crucially, substantial equivalence to predicate devices.
Reported Device Performance:
- Safety and Efficacy: Established by a series of performance tests, lab performance tests, design validation, and software verification and validation.
- Histological Analysis: Performed to align delivered energy with coagulation impact at the skin tissue level.
- Compliance with Standards:
  - IEC 60601-1 (Medical Electrical Equipment-Part 1: General Requirements for Safety-1. Collateral Standard: Safety Requirements for Medical Electrical Systems).
  - IEC 60601-1-2 (Electromagnetic compatibility (EMC)).
  - IEC 60601-2-22 ed3.0:2007 (Basic Safety and Essential Performance of Surgical, Cosmetic, Therapeutic and Diagnostic Laser Equipment).
  - IEC 60825-1:2007 (Safety of Laser Products - Part 1: Equipment Classification, Requirements and User's Guide).
- Substantial Equivalence: The device has the same intended use and indications as its predicate devices. The technology and the envelope of power and frequency are covered by the predicate devices. Minor differences in human interface and accessories do not raise new safety/effectiveness issues.

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

Not applicable/Not provided: This document does not describe a clinical study with a test set of patient data to evaluate an algorithm's performance. The "performance data" refers to engineering and bench tests, and histological analysis, not a clinical trial with a patient sample size.

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)

Not applicable/Not provided: No test set involving human expert ground truth for an algorithm is described.

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

Not applicable/Not provided: No test set involving human expert adjudication is described.

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

No: A multi-reader multi-case (MRMC) comparative effectiveness study was not performed, as this is not an AI-assisted diagnostic device.

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

Not applicable: This device is a laser module for dermatological procedures, not a standalone algorithm.

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

The closest concept to "ground truth" here is the histological analysis performed to evaluate the coagulation impact at the skin tissue level, correlating delivered energy with physical tissue effect. This serves as a "ground truth" for the device's functional effect. However, it's not "ground truth" in the context of an AI study.

8. The sample size for the training set

Not applicable/Not provided: This is not an AI/ML device, so there is no training set mentioned.

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

Not applicable/Not provided: This is not an AI/ML device, so there is no training set or associated ground truth establishment process described.

Summary of the Study that Proves the Device Meets Acceptance Criteria (as per the document):

The "study" presented here is not a clinical trial or an AI performance study, but rather a submission demonstrating:

Bench Performance Tests: These tests confirmed the Lumenis ResurFX performs its intended use safely and efficiently.
Design Validation and Software Verification/Validation: These processes ensured the device meets its specifications.
Histological Analysis: This analysis was crucial for correlating the laser's delivered energy with the expected coagulation impact on skin tissue.
Compliance with International and Medical Device Standards: The device was tested and found to comply with relevant IEC standards for medical electrical equipment and laser safety (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22 ed3.0:2007, IEC 60825-1:2007).
Substantial Equivalence to Predicate Devices: The primary argument for approval is that Lumenis ResurFX is substantially equivalent to previously cleared devices (Fraxel, Palomar Lux1540, Palomar Icon Aesthetic System) in terms of intended use, indications, technology, and power/frequency envelopes. This implies that since the predicate devices are already deemed safe and effective, and the new device is functionally similar within accepted parameters, it also meets safety and efficacy criteria without needing new clinical studies. The document explicitly states: "Based on the equivalence with predicates, and on the histological analysis performed, Lumenis believes that clinical studies are not necessary to determine the safety and efficacy of the device."

Summary

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510(K) SUMMARY

. Lumenis ResurFX

510(k) Number K130028

Applicant's Name:

Lumenis Ltd. 6 Hakidma Street Yokneam Industrial Park Yokneam 20692 Israel Tel. (972)4-959 9000 Fax: (9724-959 9050

SEP 0 3 2013

Contact Person: Yoram Levy, Qsite 31 Haavoda St. Binyamina, Israel 30500 Tel +(972)4-638-8837; Fax +(972)4-638-0510 Yoram@qsitemed.com

Trade Name: Common Name: Lumenis ResurFX Laser Module Laser Module

Summary Preparation Date: April 11, 2013

Classification:

Name: Electrosurgical, cutting & coagulation device & accessories Product Code: ONG Regulation No: 21 CFR 878.4810 Class: II Panel: General and Plastic Surgery

Device Description:

The ResurFX module is a 1565nm non ablative laser module that is an add-on to FDA cleared mainframes like the M22 (LUM 2, cleared under K083733).

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Image /page/1/Picture/0 description: The image shows the logo for Lumenis, a medical device company. The logo features a stylized letter "L" inside a circle, followed by the word "LUMENIS" in a sans-serif font. Below the company name is the tagline "Enhancing Life. Advancing Technology."

Intended Use Statement:

The 1565nm ResurFX laser module is indicated for use in dermatological procedures requiring skin resurfacing and coagulation of soft tissue

Predicate Devices: Substantial equivalence to the following predicate devices is claimed:

Device Name	510k No	Date of Clearance
Fraxel (Solta medical)1550 nm laser	K091420	Oct 14 2009
PalomarLux1540	K090195	Nov 20, 2009
Palomar Icon AestheticSystem	K110907	June 22, 2011

Performance Standards

Lumenis ResurFX complies with:

IEC 60601-1 (Medical Electrical Equipment-Part 1: General . Requirements for Safety-1. Collateral Standard: Safety Requirements for Medical Electrical Systems).
IEC 60601-1-2 (Electromagnetic compatibility (EMC) .
IEC 60601-2-22 ed3.0:2007 Medical Electrical Equipment -● Part 2-22: Particular Requirements for Basic Safety and Essential Performance of Surgical, Cosmetic, Therapeutic and Diagnostic Laser Equipment.
. IEC 60825-1:2007 - Safety of Laser Products - Part 1: Equipment Classification, Requirements and User's Guide.

A detailed description appears in Section 14:

Summary of Technologies

The ResurFX module is a 1565nm fiber laser constructed on scanner operated by scanner controller.

The system may be activated by either handpiece or footswitch trigger.

Performance Data

The safety and efficacy of the ResurFX were established by a series of performance tests. Lab performance tests, design validation and software verification and validation. Validation, verification and testing have shown that the ResurFX device performs according to its specifications.

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Image /page/2/Picture/0 description: The image shows the Lumenis logo. The logo consists of a stylized letter "L" inside a circle, followed by the word "LUMENIS" in bold, sans-serif font. Below the word "LUMENIS" is the tagline "Enhancing Life. Advancing Technology."

Summary of Clinical performance data

The Lumenis ResurFX was tested in bench performance tests to perform its intended use safely and efficiently. Lumenis has performed histological analysis to align between delivered energy and coagulation impact at the skin tissue level. Based on the equivalence with predicates, and on the histological analysis performed, Lumenis believes that clinical studies are not necessary to determine the safety and efficacy of the device.

Substantial Equivalence

Lumenis ResurFX device has the same intended use and indications as its predicate devices. The technology of the three predicates is also the same. The envelope of power and frequency of the submitted Lumenis ResurFX is covered by the envelopes of its predicate devices. Any minor differences in the human interface and accessories design do not raise any new type of safety and effectiveness issues, as verified by performance testing. Therefore the Lumenis ResurFX is substantially equivalent to its predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

Lumenis, Ltd. % QSite Yoram Levy 31 Haavoda Street Binyamina, Israel 30500

September 3, 2013

Re: K130028

Trade/Device Name: Lumenis ResurFX 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: August 02, 2013 Received: August 06, 2013

Dear Mr. Levy:

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 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

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Page 2 - Yoram Levy

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-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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm | 15809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

FOR Peter D. Rumm -S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/5/Picture/0 description: The image shows the Lumenis logo. The logo consists of a circle with a stylized "L" inside, followed by the word "LUMENIS" in bold, sans-serif font. Below the word "LUMENIS" is the tagline "Enhancing Life Advancing Technology" in a smaller font size. The logo is simple and modern, and the tagline conveys the company's mission.

INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K130028

Device Name:

Lumenis ResurFX

Indications for Use:

The 1565nm ResurFX laser module is indicated for use in dermatological procedures requiring skin resurfacing and coagulation of soft tissue

Prescription Use X (Part 21 CFR 80) Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-off) for мхм Division of Surgical Devices 510(k) Number: K130028

Neil R Ogden 2013.08.27 14:30:02 -04'00'

4 Lumenis ResurFX - 510k Notification

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.