(61 days)
Not Found
No
The summary describes a light therapy device using LEDs at specific wavelengths for dermatological conditions and pain relief. There is no mention of AI, ML, image processing, or any data-driven decision-making process. The performance studies focus on electrical safety, photobiological safety, and basic device functionality.
Yes
The device's intended use explicitly states its purpose is to "treat dermatological conditions" and alleviate "minor muscle and joint pain, arthritis and muscle spasm," which are therapeutic applications.
No
Explanation: The device is described as emitting energy to treat conditions, not to diagnose them. Its intended use focuses on therapy, such as treating dermatological conditions, pain relief, and increasing blood circulation. There is no mention of it collecting data or providing diagnostic information.
No
The device description explicitly states it uses LEDs to produce light and is equipped with two irradiators with panels, indicating it is a hardware device that emits light for treatment. The performance studies also include electrical safety, electromagnetic compatibility, and photobiological safety testing, which are relevant to hardware devices. While software verification and validation are mentioned, this is for controlling the hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is intended to "emit energy to treat dermatological conditions" and provides specific therapeutic indications for different wavelengths of light (treating lesions, acne, wrinkles, pain, etc.). This describes a therapeutic device, not a diagnostic one.
- Device Description: The description focuses on how the device produces and delivers light energy for treatment.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze samples (like blood, urine, tissue), detect biomarkers, or provide information for diagnosis. IVD devices are designed to perform tests on samples taken from the human body to provide information about a person's health status.
In summary, the ELIXIR MD™ is a light therapy device intended for therapeutic treatment, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
ELIXIR MDTM use of the red, blue, Yellow and infrared regions of the spectrum is intended to emit energy to treat dermatological conditions.
The red light (633±10nm wavelength) is generally indicated to treatment of superficial, benign vascular, and pigmented lesions.
The blue light (417±10 nm wavelength); is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.
The Yellow light (590±10nm wavelength) is generally indicated to treat dermatological conditions and specifically indicated for treatment of periorbital wrinkles and rhytides.
The infrared light (835±15nm wavelength) is generally use for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The ELIXIR MD™ uses specific wavelengths of light, produced by LEDs (light emitting diodes), to manage aesthetic conditions.
The device produces light in the red-light region of the spectrum (633 ± 10m), in the blue light regions of the light spectrum (417 ± 10m), the yellow light area (590 ± 10nm) and the infrared light region of the light spectrum (835 ± 15m).
The ELIXIR MD™ is equipped with two irradiators. The RBY irradiator has five panels, each of which emits three different colors of light sources (red light, yellow light); The RBI irradiator has five panels. Each panel emits three different colors of light sources (red light, blue light, infrared light).
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
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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 Tests Performed:
Electrical Safety and Electromagnetic Compatibility Testing – The device has been tested and meets the following standard requirements of medical equipment:
- IEC60601-1: 2005+2005+CORR.1:2006+CORR.2:2007+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.
- IEC 60601-2-57:2011 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility - Requirements and tests.
Photobiological Safety Testing – The device has been tested and comply with IEC 62471:2006, Photobiological safety of lamps and lamp systems, 1st edition.
This IEC standard incorporates the principles of the following ANSI IESNA recommended practices:
- RP 27.1:2005 Recommended practice for photobiological safety for lamps and lamp systems -General requirements.
- RP 27.2:2000 Recommended practice for photobiological safety for lamps and lamp systems -Measurement techniques.
- RP-27.3:2007 Recommended practice for photobiological safety for lamps and lamp systems –Risk group classification and labeling.
Software Verification and Validation - Software documentation consistent with moderate level of concern was submitted in this 510(k). System validation testing presented in this 510(k) demonstrated that all software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels.
Bench Test Summary:
Performance Test (Appearance; Spectral peak wavelength; Effective irradiance; Timing and functions; Effective radiation area; Stand adjustment; Changeable treatment head; Uniformity of effective red light irradiance; Working noise; Protective grounding impedance; Continuous leakage current at normal operating temperature; Dielectric strength at normal operating temperature; Packing inspection).
The device passed all the tests mentioned above.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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).
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.
0
Image /page/0/Picture/0 description: The image contains 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 logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.
July 8, 2024
Yassen Wellness LLC Elias Michael Head of R&D 1881 Von Karman Ave Suite 1170 Irvine, California 92612
Re: K241293
Trade/Device Name: LED Light Therapy Device, ELIXIR MDTM 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: April 12, 2024 Received: May 8, 2024
Dear Elias Michael:
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/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
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). 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,
Digitally signed by Yan Fu -S
Yan Fu -S Date: 2024.07.08 17:25:11
-04'00'
for
Tanisha Hithe Assistant Director DHT4A: Division of General Surgery Devices
2
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) K241293
Device Name LED Light Therapy Device Model: ELIXIR MDTM
Indications for Use (Describe)
ELIXIR MDTM use of the red, blue, Yellow and infrared regions of the spectrum is intended to emit energy to treat dermatological conditions.
The red light (633±10nm wavelength) is generally indicated to treatment of superficial, benign vascular, and pigmented lesions.
The blue light (417±10 nm wavelength); is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.
The Yellow light (590±10nm wavelength) is generally indicated to treat dermatological conditions and specifically indicated for treatment of periorbital wrinkles and rhytides.
The infrared light (835±15nm wavelength) is generally use for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
510k Summary (K241293)
Table of Contents
| 510k Summary (K241293) | 1 | |
|---|---|---|
| 1. | Submitter's Identifications | 2 |
| 2. | Correspondent's Identifications | 2 |
| 3. | Date Prepared | 2 |
| 4. | Name of the Device | 2 |
| 5. | The Predicate Device: | 2 |
| 6. | Device Description | 2 |
| 7. | Indications for Use | 3 |
| 8. | Summary of Substantial Equivalence | 3 |
| 9. | Substantial Equivalence discussion | 8 |
| 10. | Non-Clinical Tests Performed | 9 |
| 11. | Conclusion | 10 |
5
Device Name- LED Light Therapy Device
Model Name- ELIXIR MD™
1. Submitter's Identifications
Submitter's Name: YASSEN WELLNESS LLC Address: 1881 Von Karman Ave, Suite 1170 Irvine, CA 92612 USA Contact Person: Ewan Yassen Contact Title: CEO Contact E-mail Address: ewan@yassenwellness.com Telephone: +1 646-546-8766
2. Correspondent's Identifications
Correspondent Name: YASSEN WELLNESS LLC Address: 1881 Von Karman Ave, Suite 1170 Irvine, CA 92612 USA Contact Person: Micheal Elias Contact Title: Head of R&D Contact E-mail Address: Michaelelias@yassenwellness.com Telephone: +1(949)695-7727
3. Date Prepared
06 July 2024
4. Name of the Device
Device Classification Name: Laser surgical instrument for use in general and plastic surgery and in dermatology
Trade Name: LED Light Therapy Device
Model: ELIXIR MD™
510(K) Number: K241293
Classification Panel: General & Plastic Surgery
Product Code: GEX
Device Classification: Class II
Regulation Number: 21 CFR878.4810
5. The Predicate Device:
K222751 LED Light Therapy Device, KN-7000L
6. Device Description
The ELIXIR MD™ uses specific wavelengths of light, produced by LEDs (light emitting
diodes), to manage aesthetic conditions.
6
The device produces light in the red-light region of the spectrum (633 ± 10m), in the blue light regions of the light spectrum (417 ± 10m), the yellow light area (590 ± 10nm) and the infrared light region of the light spectrum (835 ± 15m).
The ELIXIR MD™ is equipped with two irradiators. The RBY irradiator has five panels, each of which emits three different colors of light sources (red light, yellow light); The RBI irradiator has five panels. Each panel emits three different colors of light sources (red light, blue light, infrared light).
7. Indications for Use
ELIXIR MD™ use of the red, blue, Yellow and infrared regions of the spectrum is intended to emit energy to treat dermatological conditions.
The red light (633±10nm wavelength) is generally indicated to treatment of superficial, benign vascular, and pigmented lesions.
The blue light (417±10 nm wavelength); is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.
The Yellow light (590±10nm wavelength) is generally indicated to treat dermatological conditions and specifically indicated for treatment of periorbital wrinkles and rhytides.
The infrared light (835±15nm wavelength) is generally use for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.
8. Summary of Substantial Equivalence
A comparison between the YASSEN LED Light Therapy Device ELIXIR MD™ and predicate devices have been compared with respect to indication use, technological characteristics, performance testing, and applicable standards. The subject does not raise any significant differences with the predicate device, which affects the safety and performance of the device.
7
| Item | Proposed Device | Predicate Device | Details of
equivalence |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|
| Product Code | GEX | GEX | Same |
| Regulation
Number | 21 CFR 878.4810 | 21 CFR 878.4810 | Same |
| Proprietary
Name | LED Light Therapy Device | Photodynamic Therapy
Device | - |
| Model | ELIXIR MD™ | KN-7000L | - |
| Manufacturer | YASSEN WELLNESS, LLC. | Xuzhou Kernel Medical
Equipment Co., Ltd. | - |
| Indications of
use | LED Light Therapy Device, ELIXIR MD™ use of the
red, blue, Yellow and infrared regions of the
spectrum is intended to emit energy to treat
dermatological conditions. | LED Light Therapy Device use of the red, blue,
Yellow and infrared regions of the spectrum
is intended to emit energy to treat
dermatological conditions. | Same |
| | The red light (633±10nm wavelength) is generally
indicated to treatment of superficial, benign
vascular, and pigmented lesions. | The red light (633±10nm wavelength) is generally
indicated to treatment of superficial, benign
vascular, and pigmented lesions. | |
| | The blue light (417±10 nm wavelength); is generally
indicated to treat dermatological conditions and specifically indicated
to treat moderate inflammatory acne vulgaris. | The blue light (417±10 nm wavelength); is generally indicated to
treat dermatological conditions and specifically indicated to treat moderate
inflammatory acne vulgaris. | |
| Item | Proposed Device | Predicate Device | Details of equivalence |
| | The Yellow light
(590±10nm wavelength) is generally indicated to treat dermatological conditions and specifically indicated for treatment of periorbital wrinkles and rhytides. | The Yellow light
(590±10nm wavelength) is generally indicated to treat dermatological conditions and specifically indicated for treatment of periorbital wrinkles and rhytides. | |
| | The infrared light
(835±15nm wavelength) is generally use for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied | The infrared light
(835±15nm wavelength) is generally use for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied | |
| Wavelength(s)
(nm) | RBY irradiator: (Red light 633 ± 10nm, blue light 417 ± 10nm, yellow light 590 ±10nm).
RBI irradiator: (Red 633 ± 10nm, blue 417 ± 10nm, infrared 835 ± 15nm) | RBY irradiator : (Red light 633 ± 10nm, blue light 417 ± 10nm, yellow light 590 ±10nm).
RBI irradiator: (Red 633 ± 10nm, blue 417 ± 10nm, infrared 835 ± 15nm) | Same |
| Panel Type | RBY Irradiator has 5 panels: | RBY Irradiator has 5 panels: | Same |
| | Red light:465EA LEDs; | Red light:465EA LEDs; | |
| | blue light: 470EA LEDs; | blue light: 470EA LEDs; | |
| | yellow light: 465EA LEDs; | yellow light: 465EA LEDs; | |
| Item | Proposed Device | Predicate Device | Details of equivalence |
| | RBI irradiator: has 5 panels:
Red light:465EA LEDs;
blue light: 470EA LEDs;
infrared: 465EA LEDs;
The panels may emit the three light (red, blue infrared) individual or in combination | RBI irradiator: has 5 panels:
Red light:465EA LEDs;
blue light: 470EA LEDs;
infrared: 465EA LEDs;
The panels may emit the three light (red, blue infrared) individual or in combination | |
| Output Power | Each panel has three different kinds of light-emitting diodes, and the energy power of the diode is 0.5W | Each panel has three different kinds of light-emitting diodes, and the energy power of the diode is 0.5W | Same |
| Maximum power density in Mw (mW/CM²) | Red light: 2096 mw/cm²120 mw/cm ²
Blue light: 10
Yellow light: 535 mw/cm ²96 mw/cm ²
Infrared: ≤ 70 mw/cm ²
Red/IR: 166mW/cm²,
Blue/IR: 190mW/cm² | Red light: 20
Blue light: 10120 mw/cm ²35 mw/cm ²
Yellow light: 5
Infrared: ≤ 70 mw/cm ²
Red/IR: 166mW/cm²,
Blue/IR: 190mW/cm² | Same |
| Standard dose in Joules | Red light: 2096 mw/cm²120 mw/cm ²
Blue light: 10
Yellow light: 535 mw/cm ² | Red light: 2096 mw/cm ²
Blue light: 10120 mw/cm ²35 mw/cm ² | Same |
Yellow light: 5
| Item | Proposed Device | Predicate Device | Details of equivalence |
| | Infrared: ≤ 70 mw/cm ² | Infrared: ≤ 70 mw/cm ² | |
| | Red/IR: 166mW/cm², | Red/IR: 166mW/cm², | |
| | Blue/IR: 190mW/cm² | Blue/IR: 190mW/cm² | |
| | Red/IR: 199J/cm2 | Red/IR: 199J/cm2 | |
| | Blue/IR: 228J/cm2 | Blue/IR: 228J/cm2 | |
| Adjustable
dose range | Red light: 2096 mw/cm² | Red light: 2096 mw/cm² | Same |
| | Blue light: 10120 mw/cm ² | Blue light: 10120 mw/cm ² | |
| | Yellow light: 535 mw/cm ² | Yellow light: 535 mw/cm ² | |
| | Infrared: ≤ 70 mw/cm ² | Infrared: ≤ 70 mw/cm ² | |
| | Red/IR: 20166mW/cm² | Red/IR: 20166mW/cm² | |
| | Blue/IR: 10190mW/cm² | Blue/IR: 10190mW/cm² | |
| Number of
LEDs | Red light:465EA LEDs; | Red light:465EA LEDs; | Same |
| | Blue light: 470EA LEDs; | Blue light: 470EA LEDs; | |
| | Yellow light: 465EA LEDs; | Yellow light: 465EA LEDs; | |
| | Infrared: 465EA LEDs; | Infrared: 465EA LEDs; | |
| Effective
irradiation
area: (CM²) | 900 cm²±10% | 900 cm²±10% | Same |
| Pulse mode
parameter | Turn "ON" and "OFF" at a
fixed rate | Turn "ON" and "OFF" at a
fixed rate | Same |
| Pulse mode
duration | For 2Hz flashing interval
time is 0.5s | For 2Hz flashing interval
time is 0.5s | Same |
| Item | Proposed Device | Predicate Device | Details of equivalence |
| | For 5Hz flashing interval time is 0.2s | For 5Hz flashing interval time is 0.2s | |
| | For 10Hz flashing interval time is 0.1s | For 10Hz flashing interval time is 0.1s | |
| Structural style | Wheeled | Wheeled | Same |
| Structure composition | Main frame, irradiator, lifting frame | Main frame, irradiator, lifting frame | Same |
| Power supply | AC 100-240 50/60Hz | AC 100-240 50/60Hz | Same |
| Treatment time | 20min (Recommended treatment time) | 20min (Recommended treatment time) | Same |
| Operation interface | Display screen | Display screen | Same |
| Software | Yes | Yes | Same |
| Safety classification | Class I | Class I | Same |
| Standard | IEC 60601-1
IEC 60601-1-2
IEC 60601-2-57
IEC 62471 | IEC 60601-1
IEC 60601-1-2
IEC 60601-2-57
IEC 62471 | Same |
Table 1: Comparison of characteristics
8
9
10
11
9. Substantial Equivalence discussion
There are no differences between the subject device and the predicate device. The subject and predicate devices are similar in indicated use, and technical specifications. The subjective device meets the IEC 60601-1, IEC 60601-1-2, IEC 60601-2-57, and IEC 62471 standards because of the same design as the predicate device. There are no technological differences that raise new or different questions of safety or effectiveness.
12
10. Non-Clinical Tests Performed
Electrical Safety and Electromagnetic Compatibility Testing – The device has been tested and meets the following standard requirements of medical equipment:
-
IEC60601-1: 2005+2005+CORR.1:2006+CORR.2:2007+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.
• IEC 60601-2-57:2011 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility -
Requirements and tests.
Photobiological Safety Testing – The device has been tested and comply with IEC 62471:2006, Photobiological safety of lamps and lamp systems, 1st edition.
This IEC standard incorporates the principles of the following ANSI IESNA recommended
practices:
● RP 27.1:2005 Recommended practice for photobiological safety for lamps and lamp systems -General requirements.
● RP 27.2:2000 Recommended practice for photobiological safety for lamps and lamp systems -Measurement techniques.
• RP-27.3:2007 Recommended practice for photobiological safety for lamps and lamp systems –Risk group classification and labeling.
Software Verification and Validation - Software documentation consistent with moderate level of concern was submitted in this 510(k). System validation testing presented in this 510(k) demonstrated that all software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels.
Bench Test Summary:
Performance Test (Appearance; Spectral peak wavelength; Effective irradiance; Timing and functions; Effective radiation area; Stand adjustment; Changeable treatment head; Uniformity of effective red light irradiance; Working noise; Protective grounding impedance; Continuous leakage current at normal operating temperature; Dielectric strength at normal operating temperature; Packing inspection).
13
The device passed all the tests mentioned above.
11. Conclusion
Based on comparing to predicate device, the proposed device of LED Light Therapy Device, Elixir MD™ are determined to be Substantially Equivalent (SE) to the predicate device, in respect of safety and effectiveness