BC-5 Red and Blue light in combination is intended to emit energy in the red and blue region of the spectrum to treat dermatological conditions, specifically indicated to treat mild to moderate acne vulgaris.

BC-5 Red and Infrared light in combination is intended to emit energy in the red and infrared region of the spectrum to treat dermatological conditions, specifically indicated to treat periorbital wrinkles.

BC-5 Infrared is intended to emit energy in the IR spectrum to provide topical heating for the purpose of elevating tissue temperature; 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.

Device Description

BC-5 is a light-based photobiomodulation system intended for performing non-invasive, low-level light therapy (LLT). It is used to deliver visible light wavelengths to treat dermatological conditions or to apply near infrared to the skin for topical heating.

BC-5 is a transportable, vertical system with an attached, four-panel treatment head that is manually adjusted to an appropriate distance above the patient's skin. The device does not contact the patient.

System components include a mains-powered control unit with touch-input control panel and microprocessor circuit; adjustable treatment head; and base with casters for transportability. An autolift pole connects the treatment head to the top of the main unit. An emergency stop switch allows the user to quickly shut the system down.

The technological heart of the system is RGB-IR chips (red-green-blue-near infrared). The user can select from the following five different programs, depending on type of dermatological condition and desired electromagnetic wavelength or combination of wavelengths: red, blue, red and blue, red and infrared. The first four are intended to treat skin conditions, while the fifth is intended for topical heating indications.

The entire system is reusable and is cleaned before each use.

AI/ML Overview

The provided document is a 510(k) summary for the BC-5 device, a light-based photobiomodulation system. It primarily focuses on demonstrating substantial equivalence to a predicate device (Lightwave Professional Deluxe) through comparison of features and non-clinical bench testing. It does not present clinical study data for device performance against specific acceptance criteria related to its stated indications for use (e.g., treatment of acne, wrinkles, pain relief).

Therefore, I cannot directly answer your request for acceptance criteria and a study proving the device meets those criteria with specific performance numbers, sample sizes, expert involvement, or MRMC studies, as this information is not contained within the provided 510(k) summary.

The document discusses non-clinical bench testing to demonstrate the device's safety and performance with respect to electrical safety, EMC, risk management, software, non-laser light, and usability engineering. These are tests to ensure the device itself is safe and functions as designed, not clinical efficacy trials.

Here's an attempt to structure the information based on your request, highlighting what is available and what is not:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria presented in this document are primarily related to substantial equivalence to a predicate device and adherence to non-clinical safety and performance standards, rather than clinical efficacy metrics for the specified dermatological and pain relief indications.

Acceptance Criteria Category (from document)	Specific Standard/Test	Reported Device Performance and Determination
Biocompatibility	ISO 10993-1	No testing required (does not touch patient) - Met
Software Validation	IEC 62304:2006 + A1:2015; SW Function Validation Tests	Passed - Met
Risk Management	EN ISO 14971:2012	Passed - Met
Electrical Safety	IEC 60601-1:2005 +C1:2006+C2:2007+A1:2012	Passed - Met
EMC (Electromagnetic Compatibility)	IEC 60601-1-2:2014	Passed - Met
Usability	IEC 62366-1:2015	Passed - Met
Mechanical Safety/Non-Laser Light Equipment	IEC 60601-2-57:2011	Passed - Met
Label Symbols	ISO 15223:2012	Met
Software Verification & Validation (Guidance)	FDA Guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (2005)	Performed, reports included. SW considered "minor level of concern." - Met

Important Note: This table reflects the engineering and safety performance criteria for device clearance via 510(k), not clinical efficacy outcomes for treating medical conditions. The document asserts that the device is substantially equivalent to a predicate device which already has established clinical indications, implying that similar clinical performance is expected. No new clinical studies are presented to prove the BC-5's efficacy against its indications.

2. Sample Sizes Used for the Test Set and Data Provenance

Test Set Sample Size: Not applicable. The "tests" described are non-clinical bench tests (e.g., electrical safety, EMC), not clinical trials involving patient data.
Data Provenance: Not applicable for clinical study data. The data provenance discussed relates to compliance with international standards for device manufacturing and testing.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable for the type of testing presented. Ground truth in this context refers to established engineering standards (e.g., IEC, ISO) and the device's performance against these standards. The experts involved would be engineers and quality assurance professionals performing and reviewing the bench tests.

4. Adjudication Method for the Test Set

Not applicable, as there are no clinical results needing adjudication. The testing involved passing/failing against engineering specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study is a type of clinical study typically used for diagnostic devices to assess the performance of human readers with and without AI assistance. This document describes a therapeutic device and no such clinical study is mentioned.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. The BC-5 is a physical medical device (light therapy system), not an algorithm or software-only diagnostic tool.

7. The Type of Ground Truth Used

The "ground truth" for the substantial equivalence claim is based on:

Predicate Device Equivalence: The legally marketed Lightwave Professional Deluxe (K082586) and its established indications and performance.
Compliance with Recognized Standards: International standards for medical device safety, electrical performance, software, risk management, and usability (e.g., IEC 60601-series, ISO 14971, IEC 62304, IEC 62366).
Physical and Technical Characteristics Comparison: Demonstrating that the BC-5's specifications (wavelengths, dose ranges, dimensions, power, etc.) are comparable or do not raise new safety/effectiveness concerns compared to the predicate.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI algorithm submission requiring a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable.

Summary

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Image /page/0/Picture/0 description: The image contains 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, 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.

November 1, 2019

Reveallux, Corp % John Gillespy President FDA 510k Consultants, LLC 1100 Del Lago Cir #104 Palm Beach Gardens, FL 33410

Re: K191693

Trade/Device Name: BC-5 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: June 10, 2019 Received: June 25, 2019

Dear John Gillespy:

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.

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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 medical devices and radiation-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.

Purva Pandya Acting 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

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Indications for Use

510(k) Number (if known) K191693

Device Name BC-5

Indications for Use (Describe)

BC-5 Red light is indicated for use in dermatology for treatment of superficial, benign vascular, and pigmented lesions.

BC-5 Blue light is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.

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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510(k) Summary – K191693

1. 510(k) Submitter:	Reveallux, Corp.4508 38th St, Suite 230Columbus, NE 68601Phone: 402-750-3535Email: reveallux@gmail.com
2. Company Contact:	Justin D. Linn, President
3. Date of Submission:	October 31, 2019
4. 510(k) Preparer:	John F. Gillespy, MBAFDA 510k Consulting, LLCPalm Beach Gardens, FL 33410Phone: 386-243-4332Email: john@fda510kconsultants.com
5. Device Classification:	Trade name:Common name:Device:Class:Regulation #:Product Code:	BC-5Low-Level Light Therapy DevicePowered Laser Surgical InstrumentII878.4810GEX
6. Predicate:	Applicant:Device:510(k) Number:	Lightwave Technologies, LLC (USA)Lightwave Professional DeluxeK082586

7. Device Description ...

The technological heart of the system is RGB-IR chips (red-green-blue-near infrared). The user can select from the following five different programs, depending on type of

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dermatological condition and desired electromagnetic wavelength or combination of wavelengths: red, blue, red and blue, red and infrared. The first four are intended to treat skin conditions, while the fifth is intended for topical heating indications.

The entire system is reusable and is cleaned before each use.

The following table compares wave length and dose ranges for light emitted by the subject and predicate devices:

Light	Wave Length (nm)		Dose Range (J/cm2)
	Subject (±5)	Predicate	Subject	Predicate
Red	630	630	1-138	1-168
Blue	415	420	1-72	1-68
Infrared	835	880	1-84	1-86

Table 5A Wavelengths and Dose Ranges

8. Indications For Use ...

BC-5 Red light is indicated for use in dermatology for treatment of superficial, benign vascular, and pigmented lesions.

BC-5 Blue light is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.

The device is intended for prescription use only.

1. Comparison To Predicate Device ...
  A comparison of the subject device (BC-5) to the predicate (Lightwave) follows in Table 5B.

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Characteristics	Subject Device	Predicate Device	SE or Different
Name	Reveallux BC-5	Lightwave Professional Deluxe	NA
Applicant	Reveallux, Corp	Lightwave Technologies, LLC	NA
510k Number	K191693	K082586	NA
Class	II	II	SE
Regulation #	878.481	878.481	SE
Product Code	GEX	GEX	SE
Submission Type	510(k)	510(k)	SE
Common Description	LED based system using multiplewavelengths to treat multipledermatological conditions	LED based system using multiplewavelengths to treat multipledermatological conditions	SE
Indications For Use	BC-5 Red light is indicated for use indermatology for treatment of superficial,benign vascular, and pigmented lesions.BC-5 Blue light is generally indicated totreat dermatological conditions andspecifically indicated to treat moderateinflammatory acne vulgaris. BC-5 Red andBlue light in combination is intended toemit energy in the red and blue region ofthe spectrum to treat dermatologicalconditions, specifically indicated to treatmild to moderate acne vulgaris. BC-5 Redand Infrared light in combination isintended to emit energy in the red andinfrared region of the spectrum to treatdermatological conditions, specificallyindicated to treat periorbital wrinkles. BC-5 Infrared is intended to emit energy inthe IR spectrum to provide topical heatingfor the purpose of elevating tissuetemperature; for the temporary relief ofminor muscle and joint pain, arthritis andmuscle spasm; relieving stiffness;promoting the relaxation of muscle tissue;and to temporarily increase local bloodcirculation where applied.	The Lightwave Deluxe Red lightindicated for use in dermatology fortreatment of superficial, benignvascular, and pigmented lesions. TheLightwave Deluxe Red and Blue lightcombination is intended to emitenergy in the red and blue region ofthe spectrum to treat dermatologicalconditions, specifically indicated totreat mild to moderate acne vulgaris.The Lightwave Deluxe Blue light isgenerally indicated to treatdermatological conditions andspecifically indicated to treatmoderate inflammatory acnevulgaris. The Lightwave Deluxe Redand Infrared light combination isintended to emit energy in the redand infra-red region of the spectrumfor use in dermatology for thetreatment of periorbital wrinkles. TheLightwave Deluxe Infrared Light isintended to emit energy in the IRspectrum to provide topical heatingfor the purpose of elevating tissuetemperature; for the temporary reliefof minor muscle and joint pain,arthritis and muscle spasm; relievingstiffness; promoting the relaxation ofmuscle tissue ; and to temporarilyincrease local blood circulationwhere applied.	SE
Target Population	Individuals suffering fromindicated conditions	Individuals suffering fromindicated conditions	SE
Anatomical Site	Face	Face	SE
Rx/OTC/Both	Rx	Rx	SE
System Design	Mobile workstation withhands-free mountedtreatment head.	Mobile workstation withhands-free mountedtreatment head.	SE
Dimensions	20in X 20in X 53in	24in X 58in	SE
Weight	110 lbs	84 lbs	SE
Energy Input	AC 85V~260V range, 50/60Hz	AC 110V or 220V, 50/60 Hz	SE
Energy Output	12w per LED; 240W per panel	Not available	SE
Technology	Photobiomodulation	Photobiomodulation	SE
Light Source	LED (nonchoherent) multi-diode	LED (nonchoherent) multi-diode	SE
Treatment Head	LED array	LED array	SE
Light Output	Red, blue, IR, red/IR, red/blue	Red, blue, IR, red/IR, red/blue	SE
Wavelength--Red	$630\pm5nm$	630nm	SE
Wavelength--Blue	$415\pm5nm$	420nm	SE
Wavelength--IR	$835\pm5nm$	880nm	See discussion
Treatment Time	Up to 20 min	Up to 20 min	SE
Intensity--Red	115 mW/cm2±10%	112 mW/cm2	SE
Intensity--Blue	60 mW/cm2±10%	45 mW/cm2	SE
Intensity--IR	70 mW/cm2	57 mW/cm2	SE
Std Dose--Red	138 J/cm2	135 J/cm2	SE
Std Dose--Blue	72 J/cm2	54 J/cm2	SE
Std Dose--IR	84 J/cm2	69 J/cm2	SE
Dose Range--Red	1-138 J/cm2	1-168 J/cm2	SE
Dose Range--Blue	1-72 J/cm2	1-68 J/cm2	SE
Dose Range--IR	1-84 J/cm2	1-86 J/cm2	SE
Wave Form	CW & Variable	CW & Variable	SE
Head/LEDConfiguration	All built into one head. Nochanging of heads	All built into one head. Nochanging of heads	SE
Spot Size (Coverage)	1200 cm2 (20X15X4 panels)	Up to 1662 cm2	SE
# LEDs Per Panel	60	600	SE since subject LEDsare larger with higher
# Panels	4	1-3	power (common in
# LEDs Total	240	600-1800	market now)
Components & Accessories
Vertical Console	Yes	Yes	SE
LED Panels	Yes (4)	Yes (1-3)	SE since both deviceshave multiple panels
Accessories	Replacement RGB-IR LEDpanels	RB LED panels; R-IR LED panels;RB-IR panels	SE

Table 5B - Device Comparison Table

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Physical Characteristics

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S&E Testing

Biocompatibility	ISO 10993-1 (no testing requiredas device does not touch patient)	ISO 10993-1 (no testing requiredas device does not touch patient)
Software Validation	IEC 62304:2006 + A1:2015; SWFunction Validation Tests	SW Verification & Validation
Risk Management	EN ISO 14971:2012	ISO 14971 in SW V&V
Electrical Safety	IEC 60601-1:2005+C1:2006+C2:2007+A1:2012	IEC 60601-1	SE
EMC	IEC 60601-1-2:2014	IEC 60601-1-2
Usability	IEC 62366-1:2015	Information not available
Mechanical Safety	IEC 60601-2-57:2011	Temperature readings andfunctional tests

There is one difference between the subject (BC-5) and predicate (Lightwave) that requires discussion:

Infrared Wavelength... The subject's central IR wavelength (835 nm) is commonly used in photobiomodulation devices, while the predicate's value (880 nm) is higher. In fact, the predicate device's own predicate (K120460) centers on 830 nm, or just slightly below the subject's wavelength.

None of the differences noted in Table 5 raise new issues of safety or effectiveness.

1. Performance Testing... BC-5 was subjected to the following non-clinical bench tests. All testing standards are currently FDA recognized, and the device passed each test:
- EMC – EN 60601-1-2 Edition 4:2014... Medical Electrical Equipment – Part 1-2: General Requirements For Basic Safety And Essential Performance – Collateral Standard: Electromagnetic Disturbances – Requirements And Tests
- Electrical Safety - IEC 60601-1:2005, Mod... Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance
- Risk Management – ISO 14971:2007 (Ed 2.0)... Application of Risk Management to Medical Devices
- Software Life Cycle – IEC 62304:2015 (Ed 1.1)... Medical Device Software – Software Life Cycle Processes
- Non-Laser Light IEC 60601-2-57:2011 (Ed 1.0)... Non-Laser Light Source ● Equipment for Therapeutic.. and Cosmetic/Aesthetic Use
- Usability Engineering IEC 62366-1:2015... Medical Devices Part 1: Application of ● Usability Engineering to Medical Devices

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Label Symbols ISO 15223:2012... Symbols Used With Labels ●
1. Patient-Contacting Materials... BC-5 does not come into contact with the patient.
1. Software Verification and Validation... Software verification and validation testing were conducted in line with the requirements of FDA Guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (2005). The software for this device was considered as a "minor level of concern" and software verification and validation reports have been included in this submission.
1. Substantial Equivalence... Many of the features and technical characteristics of BC-5 (subject device) are identical to those of the Lightwave primary or GentleWaves reference devices, and where there are differences, such differences do not have an impact on the safety or effectiveness of the subject device.

BC-5 successfully followed the pathway to Substantial Equivalence in the FDA guidance document, "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications" (2014). The steps are summarized below:

The predicate and reference devices are legally marketed and were found substantially equivalent through 510(k) premarket submission.
The subject, predicate, and reference devices have the same intended use.
. Technological differences between the subject and the predicate and reference were evaluated; none of the differences raised different issues of safety and effectiveness.
The following methods for evaluation of the effects of different characteristics on safety and effectiveness were deemed acceptable-testing for electrical safety, EMC, usability engineering, and non-laser light systems for therapeutic and aesthetic purposes performance; and software life cycle documentation and risk management assessment. All evaluation methods were conducted to FDArecognized standards.
Data from these tests demonstrated equivalence and support the indications for use.

In summary, all necessary testing has been performed and the results support the conclusion that BC-5 is substantially equivalent to the legally marketed predicate and reference devices based on both (a) comparison of intended use, materials, technology, and design and (b) testing to FDA-recognized standards, and the device thus does not raise any concerns of safety or effectiveness.

Based on the information contained within this submission, it is concluded that BC-5 is substantially equivalent to the identified predicate device and warrants clearance for marketing activities.

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.