K Number
K191693
Device Name
BC-5
Manufacturer
Date Cleared
2019-11-01

(129 days)

Product Code
Regulation Number
878.4810
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended 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. 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.
More Information

Not Found

No
The device description focuses on light-based photobiomodulation and hardware components, with no mention of AI or ML algorithms for image processing, diagnosis, or treatment planning.

Yes
The device is indicated for treating various dermatological conditions (e.g., acne vulgaris, periorbital wrinkles) and for providing topical heating for temporary relief of muscle/joint pain and stiffness, all of which are therapeutic uses.

No

Explanation: The device is described as a "light-based photobiomodulation system" intended for treatment of various dermatological conditions and for topical heating. Its functions are therapeutic, not diagnostic.

No

The device description clearly outlines physical hardware components including a control unit, treatment head, base with casters, autolift pole, emergency stop switch, and RGB-IR chips, indicating it is a hardware-based system with integrated software.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections. These tests are performed outside the body.
  • Device Function: The BC-5 is a light-based photobiomodulation system that applies light energy directly to the patient's skin for therapeutic purposes (treating skin conditions, pain relief, etc.). It does not analyze samples taken from the body.
  • Intended Use: The intended uses clearly describe treatment of dermatological conditions and providing topical heating, all of which are applied externally to the patient.
  • Device Description: The description details a system that delivers light to the skin, not a system for analyzing biological samples.

Therefore, the BC-5 falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.

N/A

Intended Use / 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.

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.

Product codes (comma separated list FDA assigned to the subject device)

GEX

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Face

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)

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
  • Label Symbols ISO 15223:2012... Symbols Used With Labels ●

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.

Data from these tests demonstrated equivalence and support the indications for use.

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.

K082586

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). 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.

1

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

2

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.

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.

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."

3

510(k) Summary – K191693

| 1. 510(k) Submitter: | Reveallux, Corp.
4508 38th St, Suite 230
Columbus, NE 68601
Phone: 402-750-3535
Email: reveallux@gmail.com | | |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|--|
| 2. Company Contact: | Justin D. Linn, President | | |
| 3. Date of Submission: | October 31, 2019 | | |
| 4. 510(k) Preparer: | John F. Gillespy, MBA
FDA 510k Consulting, LLC
Palm Beach Gardens, FL 33410
Phone: 386-243-4332
Email: john@fda510kconsultants.com | | |
| 5. Device Classification: | Trade name:
Common name:
Device:
Class:
Regulation #:
Product Code: | BC-5
Low-Level Light Therapy Device
Powered Laser Surgical Instrument
II
878.4810
GEX | |
| 6. Predicate: | Applicant:
Device:
510(k) Number: | Lightwave Technologies, LLC (USA)
Lightwave Professional Deluxe
K082586 | |

7. 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

4

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:

LightWave Length (nm)Dose Range (J/cm2)
Subject (±5)PredicateSubjectPredicate
Red6306301-1381-168
Blue4154201-721-68
Infrared8358801-841-86

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.

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.

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.

5

CharacteristicsSubject DevicePredicate DeviceSE or Different
NameReveallux BC-5Lightwave Professional DeluxeNA
ApplicantReveallux, CorpLightwave Technologies, LLCNA
510k NumberK191693K082586NA
ClassIIIISE
Regulation #878.481878.481SE
Product CodeGEXGEXSE
Submission Type510(k)510(k)SE
Common DescriptionLED based system using multiple
wavelengths to treat multiple
dermatological conditionsLED based system using multiple
wavelengths to treat multiple
dermatological conditionsSE
Indications For UseBC-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. 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.The Lightwave Deluxe Red light
indicated for use in dermatology for
treatment of superficial, benign
vascular, and pigmented lesions. The
Lightwave Deluxe Red and Blue light
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.
The Lightwave Deluxe Blue light is
generally indicated to treat
dermatological conditions and
specifically indicated to treat
moderate inflammatory acne
vulgaris. The Lightwave Deluxe Red
and Infrared light combination is
intended to emit energy in the red
and infra-red region of the spectrum
for use in dermatology for the
treatment of periorbital wrinkles. The
Lightwave Deluxe Infrared Light 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.SE
Target PopulationIndividuals suffering from
indicated conditionsIndividuals suffering from
indicated conditionsSE
Anatomical SiteFaceFaceSE
Rx/OTC/BothRxRxSE
System DesignMobile workstation with
hands-free mounted
treatment head.Mobile workstation with
hands-free mounted
treatment head.SE
Dimensions20in X 20in X 53in24in X 58inSE
Weight110 lbs84 lbsSE
Energy InputAC 85V~260V range, 50/60HzAC 110V or 220V, 50/60 HzSE
Energy Output12w per LED; 240W per panelNot availableSE
TechnologyPhotobiomodulationPhotobiomodulationSE
Light SourceLED (nonchoherent) multi-diodeLED (nonchoherent) multi-diodeSE
Treatment HeadLED arrayLED arraySE
Light OutputRed, blue, IR, red/IR, red/blueRed, blue, IR, red/IR, red/blueSE
Wavelength--Red$630\pm5nm$630nmSE
Wavelength--Blue$415\pm5nm$420nmSE
Wavelength--IR$835\pm5nm$880nmSee discussion
Treatment TimeUp to 20 minUp to 20 minSE
Intensity--Red115 mW/cm2±10%112 mW/cm2SE
Intensity--Blue60 mW/cm2±10%45 mW/cm2SE
Intensity--IR70 mW/cm257 mW/cm2SE
Std Dose--Red138 J/cm2135 J/cm2SE
Std Dose--Blue72 J/cm254 J/cm2SE
Std Dose--IR84 J/cm269 J/cm2SE
Dose Range--Red1-138 J/cm21-168 J/cm2SE
Dose Range--Blue1-72 J/cm21-68 J/cm2SE
Dose Range--IR1-84 J/cm21-86 J/cm2SE
Wave FormCW & VariableCW & VariableSE
Head/LED
ConfigurationAll built into one head. No
changing of headsAll built into one head. No
changing of headsSE
Spot Size (Coverage)1200 cm2 (20X15X4 panels)Up to 1662 cm2SE
# LEDs Per Panel60600SE since subject LEDs
are larger with higher
# Panels41-3power (common in
# LEDs Total240600-1800market now)
Components & Accessories
Vertical ConsoleYesYesSE
LED PanelsYes (4)Yes (1-3)SE since both devices
have multiple panels
AccessoriesReplacement RGB-IR LED
panelsRB LED panels; R-IR LED panels;
RB-IR panelsSE

Table 5B - Device Comparison Table

6

Physical Characteristics

7

S&E Testing

| Biocompatibility | ISO 10993-1 (no testing required
as device does not touch patient) | ISO 10993-1 (no testing required
as device does not touch patient) | |
|---------------------|-----------------------------------------------------------------------|-----------------------------------------------------------------------|----|
| Software Validation | IEC 62304:2006 + A1:2015; SW
Function 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 and
functional 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

8

  • 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.