(243 days)
No
The document describes a laser module and its components, focusing on its physical construction and intended use for skin resurfacing. There is no mention of AI, ML, image processing, or any data-driven algorithms that would suggest the use of such technologies. The performance studies described are standard validation and verification tests for a medical device, not studies related to AI/ML model performance.
Yes
The device is indicated for "dermatological procedures requiring skin resurfacing and coagulation of soft tissue," which are therapeutic applications.
No
Explanation: The device is a laser module described for "dermatological procedures requiring skin resurfacing and coagulation of soft tissue," which are treatment functionalities, not diagnostic ones.
No
The device description explicitly lists hardware components such as a laser module, scanner, power supply, cooling unit, and handpiece.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "dermatological procedures requiring skin resurfacing and coagulation of soft tissue." This describes a therapeutic or cosmetic procedure performed directly on the patient's skin, not a test performed on a sample taken from the body.
- Device Description: The description details a laser system designed to deliver energy to the skin. This is consistent with a therapeutic or cosmetic device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The 1565nm ResurFX laser module is indicated for use in dermatological procedures requiring skin resurfacing and coagulation of soft tissue
Product codes
ONG
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).
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Image /page/0/Picture/0 description: The image shows the Lumenis logo. The logo consists of a stylized letter 'L' enclosed in a circle, followed by the word 'LUMENIS' in a sans-serif font. Below the word 'LUMENIS', there is a tagline that reads 'Enhancing Life. Advancing Technology.'
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).
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.
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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 |
| Palomar | ||
| Lux1540 | K090195 | Nov 20, 2009 |
| Palomar Icon Aesthetic | ||
| System | 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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Image /page/3/Picture/0 description: The image shows a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized abstract symbol to the right, resembling a person with outstretched arms or a bird in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
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'
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4 Lumenis ResurFX - 510k Notification