(218 days)
Not Found
No
The device description focuses on LED technology and photobiostimulation, with no mention of AI or ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The device is described as treating "superficial, benign vascular and pigmented lesions" and "moderate inflammatory acne vulgaris," indicating a therapeutic purpose to alleviate or cure medical conditions.
No
The device description and intended use clearly state that it is used for treatment of dermatological conditions (vascular and pigmented legions, and acne vulgaris) using LED light, not for diagnosis.
No
The device description explicitly states the use of "high-end Light Emitting Diodes (LED's)" and "Genesis LED Wands" which are hardware components emitting light. This is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the treatment of dermatological conditions (vascular and pigmented lesions, inflammatory acne vulgaris). This is a therapeutic use, not a diagnostic one.
- Device Description: The device uses LED light therapy applied directly to tissue. This is a physical treatment method, not a method for examining specimens from the body.
- 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 used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is to treat conditions by applying light to the skin.
N/A
Intended Use / Indications for Use
| LED Color | Wavelength | Indication: |
|---|---|---|
| Red | 627nm | Generally indicated for use in dermatology for the treatment of superficial, benign vascular and pigmented legions |
| Blue | 415nm | Generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris |
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The Genesis LED Device uses high-end Light Emitting Diodes (LED's) to distribute the specific wavelengths of light it uses. This technology is commonly referred to as Photobiostimulation, Light Emitting Diode Therapy (LEDT), or LED's. The application of LED's to tissue is non-invasive. The Genesis LED Wands emit light at the following wavelengths:
| Device: | Wavelength: | Output: |
|---|---|---|
| Genesis LED Wand RED | 627 nm | 135mW/cm², pulsed 50% duty cycle |
| Genesis LED Wand BLUE | 415 nm | 135mW/cm², pulsed 50% duty cycle |
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
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance data in the form of clinical trials were not necessary as the device uses the same technology and intended use as the predicate devices.
Testing information demonstrating safety and effectiveness of the Genesis LED wands in the intended environment of use are supported by testing that was conducted in accordance with the following standard(s): ISO 14971: 2009
Biocompatibility testing was not performed as the Genesis LED Wands do not make contact with the skin at any time before or during treatments.
Testing to demonstrate compliance to the recognized electrical safety and EMC requirements of IEC 60601-1 and IEC 60601-1-2 have been performed by an independent, accredited laboratory.
Testing to determine laser classification according to IEC 60825-1 was performed by an independent, accredited laboratory.
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.
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2 7 2013 NOV
510(K) Summary
This summary of 510(k) information is being submitted in accordance with the requirements of 21 CFR 1040.10 & 1040.11
| 1. General Information | |
|---|---|
| Submitter: | Genesis Biosystems, Inc. |
| 1500 Eagle Court | |
| Lewisville, TX 75057 | |
| 972-315-7888 (direct) | |
| 972-315-7818 (fax) | |
| Contact Person: | Jim Lafferty |
| President | |
| Genesis Biosystems, Inc. | |
| 1500 Eagle Court Lewisville, TX 75057 | |
| jgroves@genesisbiosystems.com | |
| Manufacturing Facility: | Genesis Biosystems, Inc. |
| 1500 Eagle Court | |
| Lewisville, TX 75057 | |
| Summary Preparation Date: | 15-April-2013 |
| 2. Names | |
| Device Name: | Genesis LED Device |
| Common Name: | Laser instrument, surgical, powered |
| Regulation: | 878.4810 |
| Product Code: | GEX |
3. Predicate Devices
Revitalight Skincare System (K042630) Lightwave Deluxe (K082586)
4. Device Description
The Genesis LED Device uses high-end Light Emitting Diodes (LED's) to distribute the specific wavelengths of light it uses. This technology is commonly referred to as Photobiostimulation, Light Emitting Diode Therapy (LEDT), or LED's. The application of LED's to tissue is non-invasive. The Genesis LED Wands emit light at the following wavelengths:
| Device: | Wavelength: | Output: |
|---|---|---|
| Genesis LED Wand RED | 627 nm | 135mW/cm², pulsed 50% duty cycle |
| Genesis LED Wand BLUE | 415 nm | 135mW/cm², pulsed 50% duty cycle |
5. Indications for Use
| LED Color | Wavelength | Indication: |
|---|---|---|
| Red | 627nm | Generally indicated for use in dermatology for the treatment of superficial, |
| benign vascular and pigmented legions | ||
| Blue | 415nm | Generally indicated to treat dermatological conditions and specifically |
| indicated to treat moderate inflammatory acne vulgaris |
1
6. Performance Data
Based upon an analysis of the overall performance characteristics for the device, Genesis Biosystems, Inc. believes that no significant differences exist between the Genesis LED Wands and the predicate devices referenced in this document.
7. Comparison to Predicate Devices
| Decision Process | Decision | K042630 | K082586 |
|---|---|---|---|
| Does new device have same | |||
| Indication Statement (as marketed | |||
| device? | Yes. The Genesis LED | ||
| Wand device has the | |||
| same intended use as | |||
| predicate devices noted. | The RevitaLight | ||
| Skin Care System | |||
| generally | |||
| indicated to treat | |||
| dermatological | |||
| conditions and | |||
| specifically | |||
| indicated to treat | |||
| moderate | |||
| inflammatory | |||
| acne vulgaris (Blue | |||
| Pulsars) | The LightWave Deluxe Red light is indicated | ||
| for use in dermatology for treatment of | |||
| superficial, benign vascular, and pigmented | |||
| legions. (Red Pulsars) | |||
| Does new device have same | |||
| technological characteristics, e.g., | |||
| design, materials, etc? | Yes. The Genesis LED | ||
| Wand device has the | |||
| same technological | |||
| characteristics utilizing | |||
| light emitting diodes, a | |||
| power source and means | |||
| of controlling both. | Base unit contains | ||
| power supplies | |||
| and control unit. | |||
| Pulsator | |||
| attachments | |||
| contain the light | |||
| emitting diodes | |||
| and connect to | |||
| the base unit. | The base unit contains the power supplies and | ||
| the control unit. The LED panel is attached to | |||
| the end of the arms and then positioned for | |||
| patient treatment. | |||
| Are the descriptive characteristics | |||
| precise enough to ensure | |||
| equivalence ? | Yes. The devices are | ||
| sufficiently characterized | |||
| to ensure equivalence. | Operates as blue | ||
| (420nm), yellow | |||
| (590nm), and red | |||
| (625nm) LED | |||
| source at | |||
| 80mW/cm². LED | |||
| array panel hand | |||
| held device. | Operates as red (630nm to 830nm) LED | ||
| source at 4.73J/cm². | |||
| Performance data demonstrate | |||
| equivalence? | Yes. The device | ||
| performance | |||
| demonstrates | |||
| equivalence. | Operates | ||
| equivalently as | |||
| yellow (590nm) | |||
| and red (625 nm) | |||
| LED source. | Operates equivalently as a red (630nm- | ||
| 645nm) LED source. |
2
8. Testing
Performance data in the form of clinical trials were not necessary as the device uses the same technology and intended use as the predicate devices.
Testing information demonstrating safety and effectiveness of the Genesis LED wands in the intended environment of use are supported by testing that was conducted in accordance with the following standard(s): ISO 14971: 2009
Biocompatibility testing was not performed as the Genesis LED Wands do not make contact with the skin at any time before or during treatments.
Testing to demonstrate compliance to the recognized electrical safety and EMC requirements of IEC 60601-1 and IEC 60601-1-2 have been performed by an independent, accredited laboratory.
Testing to determine laser classification according to IEC 60825-1 was performed by an independent, accredited laboratory.
9. Conclusion
Based upon an analysis of the overall characteristics for the device in comparison to the predicates, Genesis Biosystems, Inc. concludes that the Genesis LED Wands are substantially equi
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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 20993-00002
Genesis Biosystems, Incorporated Mr. Jim Lafferty President 1500 Eagle Court Lewisville, Texas 75057
November 27, 2013
Re: K131142
Trade/Device Name: Genesis LED Wands 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: October 16, 2013 Received: October 17, 2013
Dear Mr. Lafferty:
We have reviewed vour 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. Ilsting 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 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
4
Page 2 - Mr. Jim Lafferty
forth in the quality systems (OS) 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ReportaProblem/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,
Joshua C. Nipper -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director Division of Surgical Devices Office of Device Evaluation
For
Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K131142
Device Name: Genesis LED Wands
Indications For Use:
| Led Color | Wavelength | Indication: |
|---|---|---|
| Red | 627nm | Generally indicated for use in dermatology for treatment of superficial, benign vascular and pigmented lesions |
| Blue | 415nm | Generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris. |
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
Joshua C. - C
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