Who is the manufacturer of BC-5?

Reveallux, Corp filed the 510(k) submission for BC-5 (K191693).

What is the FDA product code for BC-5?

GEX. It is classified under 21 CFR 878.4810 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for BC-5?

510(k) clearance (submission type: Abbreviated).

What are the predicate devices for BC-5?

Lightwave Professional Deluxe (K082586).

Who can help prepare an FDA 510(k) submission like BC-5?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

BC-5

K191693 · Reveallux, Corp · GEX · Nov 1, 2019 · General, Plastic Surgery

Device Facts

Record ID	K191693
Device Name	BC-5
Applicant	Reveallux, Corp
Product Code	GEX · General, Plastic Surgery
Decision Date	Nov 1, 2019
Decision	SESE
Submission Type	Abbreviated
Regulation	21 CFR 878.4810
Device Class	Class 2
Attributes	Therapeutic

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 Story

BC-5 is a transportable, non-contact photobiomodulation system; uses multi-diode LED arrays to emit red, blue, and infrared light; operated by clinicians in a clinical setting via a touch-input control panel. System comprises a mains-powered control unit, autolift pole, and four-panel treatment head. User selects from five programs based on wavelength/combination; device delivers energy to skin to treat dermatological conditions or provide topical heating. Output affects clinical decision-making by providing non-invasive therapeutic light energy; benefits patients through lesion treatment, acne management, wrinkle reduction, and pain relief. System includes emergency stop switch for safety.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included EMC (EN 60601-1-2), electrical safety (IEC 60601-1), risk management (ISO 14971), software life cycle (IEC 62304), non-laser light source performance (IEC 60601-2-57), and usability engineering (IEC 62366-1).

Technological Characteristics

Photobiomodulation system; non-contact; LED (non-coherent) multi-diode light source; wavelengths: Red (630±5nm), Blue (415±5nm), IR (835±5nm); 240 LEDs total (4 panels); mains-powered (85V-260V); microprocessor-controlled; mobile vertical console; IEC 60601-1, IEC 60601-1-2, IEC 60601-2-57 compliant.

Indications for Use

Indicated for dermatology patients requiring treatment of superficial, benign vascular, and pigmented lesions; moderate inflammatory acne vulgaris; mild to moderate acne vulgaris; periorbital wrinkles; or topical heating for relief of minor muscle/joint pain, arthritis, muscle spasm, stiffness, and increased local blood circulation.

Regulatory Classification

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.

Predicate Devices

Lightwave Professional Deluxe (K082586)

Reference Devices

GentleWaves (not specified)
K120460 (predicate to Lightwave)

Related Devices

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K230342 — Phototherapy System (OL-PDT950) · Shanghai Omni Laser Skinology Co., Ltd. · Aug 16, 2023
K243993 — Photon Therapy Apparatus (BL-10) · Xemis Medical Technology (Shenzhen) Co., Ltd. · Mar 13, 2025
K082586 — LIGHTWAVE PROFESSIONAL DELUXE · Lightwave Technologies, LLC · Jan 4, 2010

Submission Summary (Full Text)

{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: | 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. 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. - 9. Comparison To Predicate Device ... A comparison of the subject device (BC-5) to the predicate (Lightwave) follows in Table 5B. {5}------------------------------------------------ | 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 multiple wavelengths to treat multiple dermatological conditions | LED based system using multiple wavelengths to treat multiple dermatological conditions | SE | | 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 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 Population | Individuals suffering from indicated conditions | Individuals suffering from indicated conditions | SE | | Anatomical Site | Face | Face | SE | | Rx/OTC/Both | Rx | Rx | SE | | System Design | Mobile workstation with hands-free mounted treatment head. | Mobile workstation with hands-free mounted treatment 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%…