(123 days)
No
The summary describes a hardware-based LED system with standard control software, and there are no mentions of AI, ML, or related concepts in the device description, intended use, or performance studies.
Yes
The device is intended for non-invasive lipolysis, which is a therapeutic treatment to reduce fat. While it is marketed as non-invasive, it addresses a physical condition (fat reduction) in individuals and uses LED technology to achieve this effect, aligning with the definition of a therapeutic device.
No
The device is described as an LED technology-based system intended for "non-invasive lipolysis," which is a treatment for fat reduction, not a diagnostic purpose.
No
The device description explicitly states that the ReBorn system consists of both hardware and software, including a console, applicators, power supply, cooling system, and other physical components.
Based on the provided information, the ReBorn device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- ReBorn's Function: The ReBorn device is an external, non-invasive system that uses LED technology to perform lipolysis (fat reduction) on the abdomen and flanks. It interacts directly with the patient's body, not with samples taken from the body.
- Intended Use: The intended use clearly states "non-invasive lipolysis of the abdomen and flanks in individuals." This is a therapeutic or cosmetic procedure, not a diagnostic test.
- Device Description: The description details a system with a console, applicators, cooling, and electrical systems, all designed for external application of energy to the body.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information about a patient's health status.
Therefore, the ReBorn device falls under the category of a therapeutic or cosmetic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The ReBorn device is an LED technology-based system intended for non-invasive lipolysis of the abdomen and flanks in individuals with a Body Mass Index (BMI) of 30 or less.
Product codes
PKT
Device Description
The ReBorn system is a non-invasive, LED-based system intended for non-invasive lipolysis and indicated for non-invasive lipolysis of the abdomen and flanks.
The Lightfective ReBorn System is a Light Emitting Diode (LED) system, generating optical energy at 1050mm. The ReBorn's cooling and electrical systems maintain safe and comfortable skin surface temperatures. The Lightfective ReBorn system delivers power of up to 49 Watts (per each applicator) in continuous wave (CW) mode. The device consists of hardware and software. These elements are integrated in the ReBorn console and applicator/handpiece. The ReBorn system is supplied as a console and 4 identical applicators. The device is portable and was specifically designed to be utilized in clinic environments.
The console is floor-standing and portable. It is controlled by a touch screen and consists of the following subsystems:
- Power Supply
- Main Controller unit (CPU)
- Water cooling system (Chiller)
- Touchscreen display monitor
- System on Module (SOM) and proprietary software
- Applicator docking panel (cradle)
- Four designated applicator connector ports
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdomen and flanks
Indicated Patient Age Range
Adult subjects
Intended User / Care Setting
Clinic environments
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical (Bench) Performance Data:
- Temperature Control Test: evaluated the accuracy of the ReBorn temperature sensors, by comparing the temperature measured by the temperature sensors of the ReBorn device to calibrated thermocouples.
- Cooling Capacity Test: evaluated the cooling capacity of the system's cooling unit during various types of treatments and verified that the cooling temperature remains within the predetermined range at all times.
- Applicator Power Performance Test: verified that the deviation between the user-set power and the actual power output from the applicator falls within the permitted range.
- Applicator Contact Sensor Test: tested the functionality of the contact sensors in multiple scenarios and demonstrated the proper display of the sensor indicator lights according to the device functionality.
- Lifetime Rationale: the expected life time or operational life of the ReBorn device and the applicator were evaluated.
- Ex-vivo Animal Study: evaluated the thermal effect of the ReBorn device on porcine abdominal skin and adipose tissue and demonstrated substantial equivalence to the FDA-cleared, predicate device, i.e., the Venus Bliss™.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.5400 Low level laser system for aesthetic use
(a)
Identification. A Low Level Laser System for Aesthetic Use is a device using low level laser energy for the disruption of adipocyte cells within the fat layer for the release of fat and lipids from these cells for noninvasive aesthetic use.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Low Level Laser System for Aesthetic Use.” See § 878.1(e) for the availability of this guidance document.
0
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 20, 2024
LightFective Ltd. % Ahava Stein Regulatory Consultant A. Stein - Regulatory Affairs Consulting Ltd. 18 Hata'as Str. Kfar Saba, 4442518 Israel
Re: K233962
Trade/Device Name: ReBorn (1050nm) Regulation Number: 21 CFR 878.5400 Regulation Name: Low level laser system for aesthetic use Regulatory Class: Class II Product Code: PKT Dated: December 14, 2023 Received: December 15, 2023
Dear Ahava Stein:
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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrb/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
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).
2
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-devices/deviceadvice-comprehensive-regulatory-assistance/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.
Tanisha L. Digitally signed by Hithe -S _ Date: 2024.06.20
19:17:29 -04'00'
Tanisha Hithe 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
3
Indications for Use
510(k) Number (if known) K233962
Device Name ReBorn (1050)
Indications for Use (Describe)
The ReBorn device is an LED technology-based system intended for non-invasive lipolysis of the abdomen and flanks in individuals with a Body Mass Index (BMI) of 30 or less.
| 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)
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4
510(K) SUMMARY
LIGHTFECTIVE REBORN DEVICE
510(k) Number K233962
| Applicant Name: | Lightfective Ltd. |
|---|---|
| Company Name: | 2 Hatochen Str. |
| Caesarea, 3079533, Israel. | |
| Tel: +972-54-3003187 | |
| E-mail: bahat@lightfective.com | |
| Contact Person: | |
| Official Correspondent: | Ahava Stein |
| Company Name: | A. Stein - Regulatory Affairs Consulting Ltd. |
| Address: | 18 Hata'as Str., Suite 21 |
| Kfar Saba 4442520 Israel | |
| Tel: + 972-9-7670002 | |
| Fax: +972-9-7668534 | |
| E-mail: ahava@asteinrac.com | |
| Date Prepared: | April 10, 2024 |
| Trade Name: | ReBorn |
| Classification Name: | CFR Classification section 878.5400; (Product Code PKT) |
| Classification: | Class II Medical Device |
| Predicate Device: |
The ReBorn device is substantially equivalent to the following predicate device:
| Manufacturer | Device Predicate | 510(k) No. |
|---|---|---|
| Venus Concept Ltd. | Venus Bliss | K190743 |
5
ReBorn Device 510(k)
Device Description:
The ReBorn system is a non-invasive, LED-based system intended for non-invasive lipolysis and indicated for non-invasive lipolysis of the abdomen and flanks.
The Lightfective ReBorn System is a Light Emitting Diode (LED) system, generating optical energy at 1050mm. The ReBorn's cooling and electrical systems maintain safe and comfortable skin surface temperatures. The Lightfective ReBorn system delivers power of up to 49 Watts (per each applicator) in continuous wave (CW) mode. The device consists of hardware and software. These elements are integrated in the ReBorn console and applicator/handpiece. The ReBorn system is supplied as a console and 4 identical applicators. The device is portable and was specifically designed to be utilized in clinic environments.
The console is floor-standing and portable. It is controlled by a touch screen and consists of the following subsystems:
- . Power Supply
- Main Controller unit (CPU)
- Water cooling system (Chiller) ●
- Touchscreen display monitor ●
- System on Module (SOM) and proprietary software
- Applicator docking panel (cradle) ●
- Four designated applicator connector ports .
Intended Use/Indication for Use:
The ReBorn device is an LED technology-based system intended for non-invasive lipolysis of the abdomen and flanks in individuals with a Body Mass Index (BMI) of 30 or less.
Performance Standards:
The ReBorn device complies with the following FDA recognized consensus standards:
- IEC 60601-2-57 Edition 1.0 2011-01 Medical electrical equipment Part 2-57: . Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic. diagnostic, monitoring and cosmetic/aesthetic use
- . 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
- 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 forbasic safety and essential performance
6
- IEC 60601-1-6 Edition 3.2 2020-07 CONSOLIDATED VERSION Medical electrical . equipment - Part 1-6: General requirements for basic safety and essential performance -Collateral standard: Usability
- ISO 10993-5 Third edition 2009-06-01 Biological evaluation of medical devices ●
- Part 5: Tests for in vitro cytotoxicity ●
- ISO 10993-10 Third Edition 2010-08-01 Biological evaluation of medical devices ●
- Part 10: Tests for irritation and skin sensitization .
- IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION Medical device software ● - Software life cycle processes
- ISO 14971 Medical devices Application of risk management to medical devices .
Non-Clinical (Bench) Performance Data:
Following is a description of the non-clinical performance tests performed on the device and provided in the 510(k) submission:
- . Temperature Control Test - evaluated the accuracy of the ReBorn temperature sensors, by comparing the temperature measured by the temperature sensors of the ReBorn device to calibrated thermocouples.
- . Cooling Capacity Test - evaluated the cooling capacity of the system's cooling unit during various types of treatments and verified that the cooling temperature remains within the predetermined range at all times.
- Applicator Power Performance Test verified that the deviation between the user-set ● power and the actual power output from the applicator falls within the permitted range.
- . Applicator Contact Sensor Test - tested the functionality of the contact sensors in multiple scenarios and demonstrated the proper display of the sensor indicator lights according to the device functionality.
- Lifetime Rationale the expected life time or operational life of the ReBorn device and . the applicator were evaluated.
- Ex-vivo Animal Study evaluated the thermal effect of the ReBorn device on porcine . abdominal skin and adipose tissue and demonstrated substantial equivalence to the FDA-cleared, predicate device, i.e., the Venus Bliss™.
Animal Performance Data / Histology Data:
Not Applicable
Clinical Performance Data:
Not Applicable
7
Substantial Equivalence:
The ReBorn system is substantially equivalent to the Venus Bliss device (Venus Concepts USA Inc.) cleared by FDA in 510(k) K190743.
| Characteristic | Subject Device
ReBorn
(Lightfective Ltd.) | Predicate Device
Venus Bliss
(Venus Concepts USA Inc., K190743 |
|-----------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Classification, Indication for Use, Intended Use | | |
| Device Classification | Class II | Class II |
| Classification Panel | General and Plastic Surgery | General and Plastic Surgery |
| Classification Product
Code | PKT | PKT |
| Regulation Number | 878.5400 | 878.5400 |
| Indications For Use | The ReBorn System is a LED
system intended for non-invasive
lipolysis of the abdomen and
flanks in individuals with a Body
Mass Index (BMI) of 30 or less. | The Venus Bliss device is a diode
laser system intended for non-
invasive lipolysis of the abdomen
and flanks in individuals with a
Body Mass Index (BMI) of 30 or
less. |
| Target Population | Adult subjects | Adult subjects |
| Anatomical Sites | Abdomen and flanks | Abdomen and flanks |
| Environment Used | Clinic | Clinic |
| Technological Characteristics | | |
| Device Description | The ReBorn is a Light Emitting Diode
(LED) system delivering optical
energy, which can disrupt adipocyte
cells to provide a non-invasive
approach to achieve a desired
aesthetic effect. The ReBorn system is
specifically indicated for treatment of
the abdomen and flanks. | The Venus Bliss device is a diode laser
system delivering optical energy, which
can disrupt adipocyte cells to provide a
non-invasive approach to achieve a
desired aesthetic effect. The Venus
Bliss is specifically indicated for
treatment of the abdomen and flanks. |
| Device Components | • Power supply unit
• Controller unit
• Cooling system
• Touchscreen display monitor
• PC and proprietary software
• 4 Applicators
• Applicator belt | • Power supply unit
• Controller unit
• Cooling System
• Touchscreen display monitor
• PC and proprietary software
• 4 Applicators
• Applicator belt |
| Energy Source | Light Emitting Diode (LED) | Diode Laser |
| Mechanism for Heat
Generation | An array of LED's delivering optical
energy | Diode laser delivering optical energy |
| Wavelength | 1050 nm + 20 nm | 1064 nm + 10 nm |
| Spot Size | 35cm2 (5x7cm) | 36cm2 (6 x 6 cm) |
| Characteristic | Subject Device
ReBorn
(Lightfective Ltd.) | Predicate Device
Venus Bliss
(Venus Concepts USA Inc., K190743 |
| Pulse Width (laser ON time) | CW | CW |
| Maximum Power Density | 1.4 W/cm² | 1.4 W/cm² |
| Attachment to Patient | Applicator Belt | Applicator Belt |
| Duration of Treatment | 25 minutes of treatment | 25 minutes of treatment |
| Treatment Temperature:
Adipose Tissue | 42-47°C | 42-47°C |
| Skin | 14°C | 14°C |
| Temperature regulation | Temperature at the applicator is
continuously monitored to ensure it
does not exceed the maximum
allowable temperature. | Temperature at the applicator is
continuously monitored to ensure it
does not exceed the maximum
allowable temperature. |
| Cooling System | Water based | Water based |
| Rate of Heating (time to
reach target temp) | 4 minutes | ~5 minutes |
| Power supply | AC/DC power:
50-60 Hz
120-240VAC
12A
Single phase | AC/DC power:
50-60 Hz
100-240VAC