(63 days)
Not Found
No
The document describes a standard diode laser hair removal system with control over pulse parameters. There is no mention of AI, ML, image processing, or any data-driven decision-making processes that would indicate the use of AI/ML. The performance studies focus on electrical and laser safety standards, and software validation, not on the performance of an AI/ML algorithm.
Yes
The device is intended for "permanent reduction in hair regrowth" and "Treatment of Pseudo folliculitis Barbae (PFB)", which are therapeutic outcomes. Additionally, it is tested against standards for "surgical, cosmetic, therapeutic and diagnostic laser equipment".
No
The provided text explicitly states the device is for "Hair removal with Static and Dynamic modes" and "Treatment of Pseudo folliculitis Barbae (PFB)". It does not mention any diagnostic capabilities or intended uses to identify or characterize a disease or condition.
No
The device description explicitly states it is a "non-invasive diode laser based system" and mentions hardware components like a "single wavelength laser diode built-in a HP" and a "10x10mm spot size." It also references hardware safety standards (IEC 60601-1, IEC 60601-1-2, 60601-2-22). While software is mentioned and verified, the core of the device is hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for hair removal and treatment of Pseudo folliculitis Barbae (PFB). These are therapeutic and cosmetic applications, not diagnostic testing performed on samples taken from the human body.
- Device Description: The device is a laser system that applies energy to the skin. It does not analyze biological samples (like blood, urine, tissue, etc.) to provide diagnostic information.
- Lack of IVD Characteristics: The description does not mention any components or processes typically associated with IVDs, such as reagents, assays, sample handling, or analysis of biological markers.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
Indications for use for the Pure Laser diode hair removal system with a 810nm applicator include:
- · Hair removal with Static and Dynamic modes intended for permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs re-growing when measured at 6,9 and 12 months after the completion of a treatment regimen.
- · Treatment of Pseudo folliculitis Barbae (PFB)
- · Use on all skin types (Fitzpatrick I-VI)
Product codes
GEX
Device Description
The PURE Laser system is a non-invasive diode laser based system used for Hair Removal. The system is based on a single wavelength laser diode built-in a HP, with a 10x10mm spot size and ability to control the pulse width, frequency and power. The Hair Removal Laser is intended for use on all skin types (Fitzpatrick skin types I-VI).
The device is sold with an electroconductive gel with prior FDA clearance – EndyGel (K161715).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
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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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Verification and validation activities were successfully completed and establish that the PURE Laser performs as intended. Testing included the following:
IEC 60601-1:2005 (Third Edition) + A1:2012 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2:2014 Medical electrical equipment, Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility Requirements and tests
60601-2-22 Edition 3.1 2012-10 Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
IEC 62304:2006 Ed.1.0 – Medical device software – software life cycle processes
Software verification and validation testing was conducted, and documentation provided in accordance with FDA's Guidance or the Content of Premarket Submissions for Software Contained in Medical Devices.
Clinical Evidence – N/A. No clinical studies were conducted as part of this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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 logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in large, bold, blue letters, and the word "ADMINISTRATION" in smaller, blue letters below.
October 7, 2022
Endymed Medical, Ltd. Ohad Fisher Regulatory Affairs Director 12 Leshem St. North Industrial Park, PO Box 3582 Caesarea, 3088900 Israel
Re: K222369
Trade/Device Name: PURE Laser 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 Dated: September 1, 2022 Received: September 1, 2022
Dear Ohad Fisher:
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Jianting Wang Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K22369
Device Name PURE Laser
Indications for Use (Describe)
Indications for use for the Pure Laser diode hair removal system with a 810nm applicator include:
- · Hair removal with Static and Dynamic modes intended for permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs re-growing when measured at 6,9 and 12 months after the completion of a treatment regimen.
- · Treatment of Pseudo folliculitis Barbae (PFB)
- · Use on all skin types (Fitzpatrick I-VI)
| 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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3
510(K) Summary PURE Laser - K222369
This 510(K) Summary of safety and effectiveness for the PURE Laser is submitted in accordance with the requirements of the SMDA 1990 and following guidance concerning the organization and content of a 510(K) summary.
| Applicant | EndyMed Medical Ltd. |
|---|---|
| Address | 12 Leshem St. North Industrial Park. |
| P.O. Box 3582 | |
| Caesarea 3088900 Israel | |
| Contact Person | Ohad Fisher, Regulatory Director |
| Contact Information | ohadf@endymed.com |
| 972-4-6309122 | |
| Preparation Date | August 5, 2022 |
| Device Trade Name | PURE Laser |
| Classification Name | Powered Laser Surgical Instrument |
| Regulation Number | 21 CFR 878.4810 |
| Product Code | GEX |
| Regulatory Class | II |
| Legally Marketed Predicate | |
| Device | Elysion-pro (K193367) |
Device Description:
The PURE Laser system is a non-invasive diode laser based system used for Hair Removal. The system is based on a single wavelength laser diode built-in a HP, with a 10x10mm spot size and ability to control the pulse width, frequency and power. The Hair Removal Laser is intended for use on all skin types (Fitzpatrick skin types I-VI).
The device is sold with an electroconductive gel with prior FDA clearance – EndyGel (K161715).
Indications for use:
Indications for use for PURE Laser diode laser hair removal system with 810nm applicator includes:
- . Hair Removal with Static (Regular) and Dynamic (DioGlide) modes intended for permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
- Treatment of Pseudo folliculitis barbae (PFB)
- Use on all skin types (Fitzpatrick I-VI).
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510(K) Summary PURE Laser - K222369
Substantial Equivalence—Technological Characteristics:
| Specification | Pure Laser (Subject Device) | Elysion-pro (K193367) | Comparison |
|---|---|---|---|
| Wavelength | 810nm | 810nm, 755nm | 810nm wavelength is the same. The PURE laser does not include a 755nm handpiece. |
| Modes | Regular Mode (Static) DioGlide (dynamic) | Static dynamic | Same |
| Fluence | 5-50J/cm² | 6-10J/cm² 40J/cm² (can go to 70J/cm2) | Similar. The predicate device fluence can be as high as 70J/cm2, but it states that treatment is conducted up to 40J/cm2. |
| Repetition Rate | 1-14Hz | 3Hz - 15Hz | Similar. The predicate device has a slightly higher range for its dynamic function, but the high-end repetition rate for the Pure Laser (14Hz) is within the range of the predicate. |
| Spot Size (mm x mm) | 10x10 | 10x10, 18x10 | Similar. The Pure laser has only one spot size, which is identical to the static spot size of the predicate. The difference in spot size for the dynamic function is minimal and does not impact the safety or efficacy of the device. |
| Pulse duration | 18-180ms | 3-400ms | Similar. The pulse duration of the Pure Laser is within the range of the predicate device. |
| Cooling Mechanism | Thermoelectric cooling | Thermoelectric Cooling | Same. |
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510(K) Summary PURE Laser - K222369
Performance Testing
Verification and validation activities were successfully completed and establish that the PURE Laser performs as intended. Testing included the following:
IEC 60601-1:2005 (Third Edition) + A1:2012 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2:2014 Medical electrical equipment, Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility Requirements and tests
60601-2-22 Edition 3.1 2012-10 Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
IEC 62304:2006 Ed.1.0 – Medical device software – software life cycle processes
Software verification and validation testing was conducted, and documentation provided in accordance with FDA's Guidance or the Content of Premarket Submissions for Software Contained in Medical Devices.
Clinical Evidence – N/A. No clinical studies were conducted as part of this submission.
Conclusion
While the devices have minor differences in the technical specifications, the PURE Laser specifications are within the range of the predicate device's specifications. The two laser perform with the same principle – higher fluence and low repetition rate for treatment of small areas on the body, and lower fluence with high repetition rate for treating large areas on the body with the dynamic mode. The differences allow for the clinician performing treatment to select the best treatment parameters for the skin/hair type and do not impact the safety and efficacy of the device. Based on the comparison and analysis above, the PURE Laser is determined to be substantially equivalent to the predicate device.