Red: Generally indicated for use in dermatology for the treatment of superficial, benign vascular and pigmented legions.
Blue: Generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.

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: Genesis LED Wand RED at 627 nm and Genesis LED Wand BLUE at 415 nm.

AI/ML Overview

The provided 510(k) summary for the Genesis LED Device indicates that no dedicated study proving the device meets specific acceptance criteria was conducted. Instead, the submission relies on demonstrating substantial equivalence to predicate devices. The performance data section explicitly states:

"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."

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment does not exist within this document in the context of a de novo study for the Genesis LED Device. The approval is based on its similarity to previously cleared devices.

However, I can extract the acceptance criteria as implied by the comparison to predicate devices and the general claims made about the device's performance.

Analysis of Implied Acceptance Criteria and Performance

The "acceptance criteria" for the Genesis LED Device are implicitly linked to its substantial equivalence to the predicate devices: Revitalight Skincare System (K042630) and Lightwave Deluxe (K082586). The device is deemed acceptable if its performance and characteristics are comparable to these already cleared devices, particularly in terms of:

Identical Indication Statement: The Genesis LED Wand must have the same intended use as the predicate devices.
Same Technological Characteristics: The device must utilize the same core technology (light-emitting diodes, power source, control).
Sufficiently Characterized Equivalence: The descriptive characteristics must be precise enough to ensure equivalence.
Performance Equivalence: The device's performance must demonstrate equivalence to the predicates.

Here's a table summarizing the stated performance relative to these implicit criteria:

1. Table of Acceptance Criteria (Implied) and Reported Device Performance

Acceptance Criterion (Implied by Substantial Equivalence)	Specifics from Predicate Devices	Reported Genesis LED Device Performance
Indication Statement Equivalence (Same intended use)	K042630 (RevitaLight): "generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris (Blue Pulsars)" K082586 (LightWave Deluxe): "Red light is indicated for use in dermatology for treatment of superficial, benign vascular, and pigmented legions."	Genesis LED Wands: - 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." (Stated as "Yes. The Genesis LED Wand device has the same intended use as predicate devices noted.")
Technological Characteristics Equivalence (Same design, materials, core technology)	K042630: "Base unit contains power supplies and control unit. Pulsator attachments contain the light emitting diodes and connect to the base unit." K082586: "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."	Genesis LED Wands: "Uses high-end Light Emitting Diodes (LED's) to distribute the specific wavelengths of light it uses. ... The Genesis LED Wand device has the same technological characteristics utilizing light emitting diodes, a power source and means of controlling both." (Stated as "Yes.")
Descriptive Characteristics Equivalence (Precise enough for equivalence)	K042630: "Operates as blue (420nm), yellow (590nm), and red (625nm) LED source at 80mW/cm². LED array panel hand held device." K082586: "Operates as red (630nm to 830nm) LED source at 4.73J/cm²."	Genesis LED Wands: - Red (627 nm): 135mW/cm², pulsed 50% duty cycle. - Blue (415 nm): 135mW/cm², pulsed 50% duty cycle. (Stated as "Yes. The devices are sufficiently characterized to ensure equivalence.")
Performance Data Equivalence	K042630: "Operates equivalently as yellow (590nm) and red (625 nm) LED source." K082586: "Operates equivalently as a red (630nm-645nm) LED source."	Genesis LED Wands: "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." (Stated as "Yes. The device performance demonstrates equivalence.")

2. Sample size used for the test set and the data provenance:

Sample Size: Not applicable. No clinical test set data was provided or used for performance evaluation, as clinical trials were deemed "not necessary."
Data Provenance: Not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. No ground truth for a test set was established as no clinical test was performed.

4. Adjudication method for the test set:

Not applicable. No test set or adjudication was performed.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is a light therapy device, not an AI-assisted diagnostic tool.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. This is not an algorithm-based device. However, the device's functional performance (wavelength and output) was implicitly evaluated by comparison to predicate technologies.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not applicable for a de novo performance study. The "ground truth" for the substantial equivalence claim rests on the already established safety and effectiveness of the predicate devices.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established:

Not applicable.

Summary of the "Study" Proving Acceptance

The "study" proving the device meets the acceptance criteria is a substantive equivalence comparison to legally marketed predicate devices, rather than a clinical trial or performance study against predefined metrics.

The manufacturer performed an analysis of the device's specifications (wavelengths, output, intended use, and technological characteristics) and compared them directly to those of the predicate devices (Revitalight Skincare System K042630 and Lightwave Deluxe K082586).
They concluded that no significant differences exist and that the device's performance demonstrates equivalence.
Non-clinical testing for safety and electrical characteristics was conducted by independent, accredited laboratories:
- ISO 14971: 2009 (Risk Management)
- IEC 60601-1 and IEC 60601-1-2 (Electrical safety and EMC)
- IEC 60825-1 (Laser classification)
Biocompatibility testing was explicitly stated as not performed because the Genesis LED Wands do not make contact with the skin.

In essence, the device's acceptance is based on the regulatory pathway of substantial equivalence, where its characteristics are demonstrated to be "as safe and effective" as legally marketed devices through comparison of specifications and existing non-clinical safety standards, rather than new clinical outcome data.

Summary

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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 CourtLewisville, TX 75057972-315-7888 (direct)972-315-7818 (fax)
Contact Person:	Jim LaffertyPresidentGenesis Biosystems, Inc.1500 Eagle Court Lewisville, TX 75057jgroves@genesisbiosystems.com
Manufacturing Facility:	Genesis Biosystems, Inc.1500 Eagle CourtLewisville, 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

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 specificallyindicated to treat moderate inflammatory acne vulgaris

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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 sameIndication Statement (as marketeddevice?	Yes. The Genesis LEDWand device has thesame intended use aspredicate devices noted.	The RevitaLightSkin Care Systemgenerallyindicated to treatdermatologicalconditions andspecificallyindicated to treatmoderateinflammatoryacne vulgaris (BluePulsars)	The LightWave Deluxe Red light is indicatedfor use in dermatology for treatment ofsuperficial, benign vascular, and pigmentedlegions. (Red Pulsars)
Does new device have sametechnological characteristics, e.g.,design, materials, etc?	Yes. The Genesis LEDWand device has thesame technologicalcharacteristics utilizinglight emitting diodes, apower source and meansof controlling both.	Base unit containspower suppliesand control unit.Pulsatorattachmentscontain the lightemitting diodesand connect tothe base unit.	The base unit contains the power supplies andthe control unit. The LED panel is attached tothe end of the arms and then positioned forpatient treatment.
Are the descriptive characteristicsprecise enough to ensureequivalence ?	Yes. The devices aresufficiently characterizedto ensure equivalence.	Operates as blue(420nm), yellow(590nm), and red(625nm) LEDsource at80mW/cm². LEDarray panel handheld device.	Operates as red (630nm to 830nm) LEDsource at 4.73J/cm².
Performance data demonstrateequivalence?	Yes. The deviceperformancedemonstratesequivalence.	Operatesequivalently asyellow (590nm)and red (625 nm)LED source.	Operates equivalently as a red (630nm-645nm) LED source.

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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

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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

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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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Regulation Number and Section

§ 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.