(87 days)
No
The device description and lack of mentions of AI/ML terms or data sets indicate it is a simple light therapy device without AI/ML.
Yes
The device is described as treating "mild to moderate acne," which is a claim of a therapeutic effect.
No
Explanation: The device is indicated for treating mild to moderate acne by emitting light, not for diagnosing it.
No
The device description clearly states it is a "lightweight, handheld device" with a "body handle and treatment head," containing LEDs, buttons, a timer, and a battery. This indicates it is a physical hardware device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. They are used outside of the body (in vitro) to diagnose, monitor, or screen for diseases or conditions.
- Luminance RED Acne Device Function: The description clearly states that the Luminance RED Acne Device is a handheld device that emits light directly onto the skin to treat acne. It does not involve the analysis of any biological specimens taken from the body.
The device description and intended use indicate it is a therapeutic device that applies energy to the body surface, not an IVD.
N/A
Intended Use / Indications for Use
The Luminance RED Acne Device is intended to enit energy in the spectrum, and is specifically indicated to treat mild to moderate acne.
Product codes
OLP
Device Description
The Luminance RED Acne Device is a lightweight, handheld device that consists of a body handle and treatment head. The body handle contains 2 LEDs that emit visible blue light (415 nm +/- 10 nm) or visible red light (660 nm +/- 10 nm) through the treatment head to help reduce the appearance of mild to moderate acne. The body consists of a plastic shell which includes a button to turn the device on/off, a button for red visible light, a button for blue visible light, and a digital countdown timer. The Luminance RED Acne Device is powered by a lithium-ion battery.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
No clinical testing was conducted as part of this 510(k) submission
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that 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.
June 9, 2022
Luminance Medical Ventures, Inc. % Laura Nygard RAQA Consultant leanRAQA, LLC 131 E Loch Lomond Dr Oro Valley, Arizona 85737
Re: K220729
Trade/Device Name: The Luminance RED Acne Device 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: OLP Dated: March 11, 2022 Received: March 14, 2022
Dear Laura Nygard:
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,
For Purva Pandya Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known)
K220729
Device Name
The Luminance RED Acne Device
Indications for Use (Describe)
The Luminance RED Acne Device is intended to enit energy in the spectrum, and is specifically indicated to treat mild to moderate acne.
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.
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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:
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SECTION 5 : 510(k) Summary
5.1 Applicant/Submitter
| Company Name | : Luminance Medical Ventures, Inc. |
|---|---|
| Establishment Registration Number | : 3020491484 |
| Phone Number | : 619-341-3848 |
| Company Street Address | : 2310 HENDERSON AVENUE #1297 |
| City | : Dallas |
| State | : Texas |
| Country | : USA |
| Zip Code | : 75201 |
5.2 Contact Person
| Full Name | : Troy Stites |
|---|---|
| Job Title | : Founder |
| Phone | : 619-341-3848 |
| : troy@luminancemedical.com |
5.3 Correspondent Information
| Full Name | : Laura Nygard |
|---|---|
| Job Title | : RAQA Consultant |
| Phone | : 734-807-1282 |
| : lauran@leanraqa.com |
5.4 Date of Preparation
| Date of Preparation | : 03/11/2022 |
|---|---|
| --------------------- | -------------- |
5.5 Device Information
Table - 5.1 Device Information
| Trade Name | The Luminance RED Acne Device |
|---|---|
| Common or Usual Name | Over-The-Counter Powered Light Based Laser For Acne |
| Classification Name | 21 CFR 878.4810 |
| Regulatory Class | 2 |
| Product Code | OLP |
5.6 Predicate Device(s)
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Table - 5.2 Predicate Device(s)
| Predicate Type | 510(k) Number | Name Of Device | Name Of Manufacturer | Product Code |
|---|---|---|---|---|
| Primary Device | K170260 | BC-001+ Acne Purifier | Oriental Inspiration Limited | OLP |
| Reference | K153081 | Clear Bi-Light | Michael Todd, LP | OLP |
5.7 Device Description
The Luminance RED Acne Device is a lightweight, handheld device that consists of a body handle and treatment head. The body handle contains 2 LEDs that emit visible blue light (415 nm +/- 10 nm) or visible red light (660 nm +/- 10 nm) through the treatment head to help reduce the appearance of mild to moderate acne. The body consists of a plastic shell which includes a button to turn the device on/off, a button for red visible light, a button for blue visible light, and a digital countdown timer. The Luminance RED Acne Device is powered by a lithium-ion battery.
5.8 Intended Use/Indications for Use
The Luminance RED Acne Device is intended to emit energy in the red and blue region of the spectrum, and is specifically indicated to treat mild to moderate acne.
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5.9 Comparison of Technological Characteristics with Predicat
Table - 5.3 Comparison Table
| Characteristics | Subject device | Predicate Device | Reference device | Substantial Equivalence Remarks |
|---|---|---|---|---|
| Device Name | The Luminance RED Acne Device | BC-001+ Acne Purifier | Clear Bi-Light | N/A |
| Applicant/Sponsor | Luminance Medical Ventures, Inc. | Oriental Inspiration Limited | Heyer Regulatory Solutions LLC | N/A |
| Product Code | OLP | OLP | OLP | Same |
| Regulation Number and Name | 21 CFR 878.4810 Laser surgical | |||
| instrument for use in general and | ||||
| plastic surgery and in dermatology. | 21 CFR 878.4810 Laser surgical | |||
| instrument for use in general and | ||||
| plastic surgery and in dermatology. | 21 CFR 878.4810 Laser surgical | |||
| instrument for use in general and | ||||
| plastic surgery and in dermatology. | Same | |||
| 510(k) Number | Not Yet Assigned | K170260 | K153081 | N/A |
| Indications for Use | Intended to emit energy in the red and | |||
| blue region of the spectrum, | ||||
| specifically indicated to treat mild to | ||||
| moderate acne. | BC-001+ Acne Purifier is | |||
| intended/indicated for over-the- | ||||
| counter use in the treatment of mild to | ||||
| moderate acne. | The Clear Bi-Light is indicated for | |||
| the treatment of mild to moderate | ||||
| inflammatory acne | Same | |||
| Energy Type | LED | LED | LED | Same |
| OTC | Yes | Yes | Yes | Same |
| Wavelength | 415 nm (+/-10 nm) | |||
| 660nm (+/-10 nm) | 415 nm ± 5 | |||
| 660 nm ± 5 | 405-420 nm | |||
| 630-660 nm | Same | |||
| Dose Rate | 4.5 Joules of each wavelength (red | |||
| and blue) | ||||
| 50 mW/cm2 for each wavelength (red | ||||
| and blue) | 50 (blue) mW/cm2 | |||
| 23 (red) mW/cm2 | 31.1 (blue) | |||
| 54.6 (red) | Similar | |||
| 6 | ||||
| 72 | ||||
| K220 | ||||
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| Characteristics | Subject device | Predicate Device | Reference device | Substantial Equivalence Remarks |
|---|---|---|---|---|
| Treatment Regimen | Hold the fiber optic tip to the area you wish to treat. It is acceptable if the fiber optic tip is not in direct contact with the skin, but the optimal placement is on or within about 0.5 inches (1 centimeter) from the treatment area. | 1.5 minutes per spot | Hold treatment face in contact with skin. Apply blue light for up to 3 minutes per skin area, followed by red light for up to 3 minutes per skin area. Can be use daily. | Similar |
| Treatment Area | Treat with 90 seconds of 415nm (blue light), then 90 seconds of 660nm (red light), 2 times per day, morning and night. | 9.1 cm² | 20 [cm2] | Similar |
| Power Supply | 0.20-3.1 cm² circle | Lithium-ion rechargeable battery AC charger: 100-240V at 50-60Hz, 500 mA Micro-USB socket for battery charging. | Lithium-ion rechargeable battery AC charger: 100-240V at 50-60Hz, 500 mA | Same |
| Lithium ion battery18650 | ||||
| Type: Lithium ion, dc | ||||
| Capacity: 2,200 mAh | ||||
| Voltage: 3.7 V | ||||
| Battery Type: 18650 | ||||
| AC charger: 100-240V at 50Hz-60Hz | ||||
| Rated charging voltage. 5V DC | ||||
| recharging current: 1.0A | ||||
| Microprocessor controlled | Yes | Unknown | Yes | Same |
| Handheld | Yes | Yes | Yes | Same |
| Software | Yes, V&V per Standard IEC 62304 | Yes, V&V per guidance | Yes, V&V per guidance | Similar |
| Safety Testing | IEC 60601-1 | |||
| IEC 60601-1-2 | ||||
| IEC 60601-1-11 | ||||
| IEC 60601-2-57 | ||||
| IEC 62471 | IEC 60601-1 | |||
| IEC 60601-1-11 | ||||
| IEC 60601-2-57 | ||||
| IEC 62471 | IEC 60601-1:2005 | |||
| IEC 60601-1-2:2007 | ||||
| IEC 62471:2006-07 | Same | |||
| Usability Testing | Yes per Guidance and IEC 62366 | Yes per Guidance | Unknown | Same |
| Characteristics | Subject device | Predicate Device | Reference device | Substantial Equivalence Remarks |
| Biocompatibility Testing | Cytotoxicity | |||
| Irritation | ||||
| Sensitization | Cytotoxicity | |||
| Irritation | ||||
| Sensitization | Cytotoxicity | |||
| Irritation | ||||
| Sensitization | Same |
Section 5, Page 4 of 6
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5.10 Standards and Guidances
5.10.1 Standards Applied
- · ISO 10993-1 Fifth edition 2018-08. Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
- · ISO 10993-5 Third edition 2009-06-01, Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity
- · ISO 10993-10 Third Edition 2010-08-01, Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
- · IEC 62471 First edition 2006-07, Photobiological safety of lamps and lamp systems
- · IEC 60601-1: 2005 + CORR. 1:2006 + CORR. 2:2007 + AM1:2012 Medical electrical equipment Part 1: General requirements for basic safety and essential performance
- · IEC 60601-1-2 Edition 4.0 2014-02, Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- · IEC 60601-1-11 Edition 2.0 2015-01, Medical electrical equipment Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
- · IEC 60601-2-57 Edition 1.0 2011-01, Medical Electrical Equipment Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic diagnostic monitoring and cosmetic/aesthetic use
- · IEC 62366-1 Edition 1.0 2015-02, Medical devices Part 1: Application of usability engineering to medical devices [Including CORRIGENDUM 1 (2016)]
5.10.2 FDA Guidances Applied
- · Use of International Standard ISO 109931 Biological evaluation of medical devices Part 1 Evaluation and testing within a risk management process Guidance for Industry and Food and Drug Administration Staff
5.11 Performance Data
5.11.1 Non Clinical
- · Usability Study
5.12 Biocompatibility Testing
- · Cytotoxicity
- · Irritation
- · Sensitization
5.13 Clinical Testing
No clinical testing was conducted as part of this 510(k) submission
5.14 Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as or better than the legally marketed predicate device.