← Product Code [OLP](/submissions/SU/subpart-e%E2%80%94surgical-devices/OLP) · K210948 # Omnilux CLEAR (K210948) _Globalmed Technologies · OLP · Jun 24, 2021 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OLP/K210948 ## Device Facts - **Applicant:** Globalmed Technologies - **Product Code:** [OLP](/submissions/SU/subpart-e%E2%80%94surgical-devices/OLP.md) - **Decision Date:** Jun 24, 2021 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4810 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery - **Attributes:** Therapeutic ## Intended Use The Omnilux CLEAR acne facemask is an over-the-counter device intended to emit energy in the red and blue region of the light spectrum, specifically indicated to treat mild to moderate acne vulgaris on the face. ## Device Story Omnilux CLEAR is an over-the-counter, flexible silicone LED phototherapy mask for home use. It emits red (630nm) and blue (412.5nm) light to treat mild to moderate acne vulgaris. The system includes a mask, a controller with a rechargeable Lithium-ion polymer battery, and a power supply. The user wears the mask on the face, secured by Velcro straps. The controller manages LED power and treatment duration via an integrated timer. The device does not perform measurements or diagnostic analysis. It is intended for patient self-administration. The output is light energy; the user observes the device status via micro-LED indicators on the controller. The device benefits patients by providing a non-invasive, light-based treatment for acne. ## Clinical Evidence No clinical data was required. The submission relied on non-clinical performance testing, including electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), photobiological safety (IEC 62471), and biocompatibility (ISO 10993). Label comprehension testing was conducted with 27 subjects (14 male, 13 female; age range 17-65) to ensure safe and effective use by lay persons. ## Technological Characteristics Flexible medical-grade silicone mask with integrated LEDs. Red wavelength: 630nm +/- 5nm; Blue wavelength: 412.5nm +/- 7.5nm. Powered by a rechargeable Lithium-ion polymer battery. Connectivity via micro-USB A-C for charging. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 62471, IEC 62133, ISO 10993-1/5/10, EN 62304, ISO 14971. ## Regulatory 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 - Acne Light Therapy Wand ([K160691](/device/K160691.md)) ## Reference Devices - Omnilux CLEAR-U ([K081307](/device/K081307.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {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. June 24, 2021 GlobalMed Technologies Lisa Thorson Director of Regulatory Affairs 163 Camino Dorado, Ste B Napa, California 94558 Re: K210948 Trade/Device Name: Omnilux CLEAR 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 18, 2021 Received: March 30, 2021 Dear Lisa Thorson: 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 mediation-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 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 Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K210948 Device Name Omnilux CLEAR Indications for Use (Describe) The Omnilux CLEAR acne facemask is an over-the-counter device intended to emit energy in the red and blue region of the light spectrum, specifically indicated to treat mild to moderate acne vulgaris on the face. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| |-------------------------------------------------|--| Prescription Use (Part 21 CFR 801 Subpart D) X 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}------------------------------------------------ Image /page/3/Picture/2 description: The image shows the logo for Omnilux Clear. The logo features a stylized sunburst design in teal on the left, followed by the word "OMNILUX" in teal. Below "OMNILUX" is the word "CLEAR," with the first half in blue and the second half in red, underlined by a line that is also blue on the left and red on the right. #### Section 5: 510(k) Summary This 510(k) Summary is submitted in accordance with 21 CFR Part 807, Section 807.92(c). Submitter's Name: Globalmed Technologies Submitter's Address: 163 Camino Dorado, Ste B Napa, CA 94558 Contact Person: Lisa Thorson Director Regulatory Affairs GlobalMed Technologies 163 Camino Dorado, Ste B Napa, CA 94558 Date Prepared: June 18th 2021 Device Trade Name: Omnilux CLEAR #### Device Classification Information: | Regulation
Number | Device Classification
name | Device
Class | Product
Code | Classification
Panel | Type | |---------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------|-----------------|-----------------|------------------------------|------------------------| | 21 CFR 878.4810
Laser surgical
instrument for use
in general and
plastic surgery and
in dermatology. | Over-The-Counter
Powered Light-Based
Laser For Acne | Class 2 | OLP | General &
Plastic Surgery | Traditional
510 (k) | {4}------------------------------------------------ Image /page/4/Picture/2 description: The image shows the logo for Omnilux Clear. The logo features a stylized sunburst graphic in teal on the left, followed by the word "OMNILUX" in teal, with "CLEAR" in a smaller font below in blue and red. A blue line is under the "OM" in Omnilux and the "CL" in Clear, and a red line is under the "UX" in Omnilux and the "EAR" in Clear. #### 5.1. Device Description The Omnilux CLEAR consists of. - Silicon flexible face mask 1. - 2. Controller - 3. Power supply and country specific adaptors - 4. USB C to USB A connector - న్. 2 x Velcro Straps The Omnilux CLEAR acne facemask is an over-the-counter device intended to emit energy in the red and blue region of the light spectrum, specifically indicated to treat mild to moderate acne vulgaris on the face. The system consists of a flexible silicon mask (1) that contains light emitting diodes (LEDs) and a controller (2). The LEDs generate the light. The mask is worn on the face Image /page/4/Picture/11 description: The image shows an Omnilux Clear LED phototherapy mask kit. The kit includes the mask itself (labeled as 1), a power adapter (2), two controllers (3), a connector (4), and straps (5). The mask and its components are neatly arranged inside a white box with the Omnilux Clear logo and the words "LED PHOTOTHERAPY MASK" printed on it. and is held in place by two adjustable Velcro straps (5). The mask compromises of 2 surfaces. An inner surface that contacts the skin and an outer surface. Both surfaces are constructed of medical grade silicon. The controller (2) switches the LEDs ON/OFF and controls power to the mask. The controller contains a rechargeable Lithium-ion polymer battery. The controller uses a visible display comprising of 3 micro-LEDs to show the user the battery charge status of the device. The power supply (3) is used to charge the Lithium battery and is connected to a suitable mains outlet via a 2 or 3 pin input socket and wall plug. The power cable is connected to the controller by a standard micro-USB A-C connector (4). The Omnilux CLEAR mask cannot be operated while charging. The equipment is not used to make measurements of any sort, or to draw any conclusions regarding the indication to treat. The equipment does not require checks on the light output as the LEDs do not dim with age to any practical extent. {5}------------------------------------------------ Image /page/5/Picture/2 description: The image shows the logo for Omnilux Clear. The logo features a stylized sunburst design on the left, followed by the word "OMNILUX" in a sans-serif font. Below "OMNILUX" is the word "CLEAR", with a blue line to the left of the word and a red line to the right. #### 5.2. Intended Use The Omnilux CLEAR acne facemask is an over-the-counter device intended to emit energy in the red and blue region of the light spectrum, specifically indicated to treat mild to moderate acne vulgaris on the face. ## 5.3. Substantial Equivalence The Omnilux CLEAR mask is substantially equivalent to the Acne Light Therapy Wand (K160691). The Omnilux CLEAR Mask is predicated against the Acne Light Therapy Wand because both devices are LED phototherapy devices intended to emit light in the red and blue region of the light spectrum and indicated for the treatment of mild to moderate acne vulgaris. {6}------------------------------------------------ Image /page/6/Picture/2 description: The image shows the logo for Omnilux CLEAR. The logo features a stylized light blue burst on the left, followed by the word "OMNILUX" in a serif font, also in light blue. Below the word "OMNILUX" is the word "CLEAR" in a sans-serif font, with the left half of the word in blue and the right half in red, each underlined with a line of the same color. #### 5.3.1 Summary of Substantial Equivalence | Description | Omnilux CLEAR | K160691
Acne Light Therapy
Wand | K081307
Omnilux CLEAR-U | Significant
differences | |----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------| | Device Manufacturer | Globalmed Technologies | Zuko, Inc | Photo Therapeutics Inc. | na | | Device Trade Name | Omnilux CLEAR™ | Acne Light Therapy
Wand | Omnilux CLEAR-UTM | na | | 510(K) Number | - | K160691 | K081307 | na | | Device Common Name | Omnilux CLEAR | Acne Light Therapy
System | Omnilux CLEAR-U | na | | Device Classification name | Over-The-Counter
Powered Light-Based
Laser for Acne | Over-The-Counter
Powered Light-Based
Laser for Acne | Light Based Over the
Counter Acne Reduction | Identical | | Device Product Code | OLP | OLP | OLP | Identical | | Regulation Number | 878.4810
Laser surgical instrument
for use in general and
plastic surgery and in
dermatology. | 878.4810
Laser surgical
instrument for use in
general and plastic
surgery and in
dermatology. | 878.4810
Laser surgical
instrument for use in
general and plastic
surgery and in
dermatology. | Identical | | Description | Omnilux CLEAR | K160691
Acne Light Therapy
Wand | K081307
Omnilux CLEAR-U | Significant
differences | | FDA Device Classification | Class II | Class II | Class II | Identical | | Use | Over the Counter | Over the Counter | Over the Counter | Identical | | Intended use and
Indications | The Omnilux CLEAR
acne facemask is an over-
the-counter device
intended to emit energy in
the red and blue region of
the light spectrum,
specifically indicated to
treat mild to moderate
acne vulgaris on the face. | The Acne Light Therapy
Wand is an over-the-
counter device that uses
a combination of blue
light and red light and is
indicated to treat mild to
moderate inflammatory
acne | The Omnilux CLEAR-U
is an over-the-counter
device that is intended
for the use in the
treatment of mild to
moderate acne vulgaris. | Identical | | Intended Location of Use | Face | Face | Face | Identical | | Energy Type | Light emitting diodes | Light emitting diodes | Light emitting diodes | Identical | | Peak Wavelength (FWHM) | Red: 630nm +/- 5nm. Blue:
412.5nm +/- 7.5nm | Red: 633 ± 4nm
Blue: 442 ± 4nm | Red: 633nm +/- 6nm
Blue:415nm +/ 5nm | Equivalent | | Intensity (mW/cm²) | Blue 28 mw/cm²
Red 16 mw/cm² | Blue 26.5 mw/cm²
Red 7.5 mw/cm² | Blue 40mw/cm2
Red 70mw/cm2 | Equivalent | | Total Intensity (mW/cm²) | 44mw/cm² | 34mw/cm² | 110 mw/cm² | Equivalent | | Description | Omnilux CLEAR | K160691
Acne Light Therapy
Wand | K081307
Omnilux CLEAR-U | Significant
differences | | Treatment time | 10 Minutes | 6 minutes1 | 20 minutes | Equivalent | | Dose | Blue 16.8J/cm2
Red 9.6J/cm2 | Blue 9.6J/cm2
Red 2.6J/cm2 | Blue 24J/cm2
Red 42J/cm2 | Equivalent | | Treatment protocol
(Treatment time) | 4 x weekly, 6 weeks | Daily | 2 x weekly, 4 weeks | Similar | | Timers | Device uses a timer and
software to control
treatment duration. | Device uses a timer and
software to control
treatment duration. | Device uses a timer and
software to control
treatment duration | Identical | | Software Controlled | Yes | Yes | Yes | Identical | {7}------------------------------------------------ Image /page/7/Picture/2 description: The image shows the logo for Omnilux Clear. The logo features a stylized light burst on the left, followed by the word "OMNILUX" in a sans-serif font. Below "OMNILUX" is the word "CLEAR", with a blue line above and a red line below. {8}------------------------------------------------ Image /page/8/Picture/2 description: The image shows the logo for Omnilux Clear. The logo features a stylized light burst on the left, followed by the word "OMNILUX" in a teal sans-serif font. Below the word "OMNILUX" is the word "CLEAR", with the first half of the word in blue and the second half in red, separated by a horizontal line. 1. Mathematically derived {9}------------------------------------------------ Image /page/9/Picture/2 description: The image shows the logo for Omnilux Clear. The logo features a stylized light burst graphic in teal, followed by the word "OMNILUX" in teal, with a trademark symbol. Below that, the word "CLEAR" is displayed, underlined with a line that transitions from blue to red. ## 5.3.2. Substantial Equivalency and Comparison of Technological Similarities & Differences From the comparative table above, the Omnilux CLEAR acne facemask demonstrates equivalence to the Acne Light therapy Wand K160691. The key similarities are; i. The intended use of the Omnilux CLEAR mask is equivalent to the listed predicates; an over-the-counter device that is intended for the use in the treatment of mild to moderate acne vulgaris. ii. Devices are phototherapy units utilizing light emitting diodes that emit in the red and blue spectrum. iii. The wavelength spectrum of the devices is equivalent. iv. The devices have a similar individual and cumulative power densities and deliver a similar single and cumulative dose over the treatment protocol course. There are therefore no significant differences between the proposed device and predicate device. Where there are differences these have been addressed by non-clinical performance testing to the following applicable standards ## 5.4. Non- clinical performance testing The Omnilux CLEAR system has been thoroughly evaluated for electrical safety and performance and has been found to conform to the following standards. IEC/EN 60601-1: 2006 + A12:2014 Medical electrical equipment Part 1: General requirements for basic safety and essential performance. IEC/EN 60601-1-2: 2015 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests including FCC 47 CFR Part 15, Sub Part B IEC 60601-1-11:2015 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 62471:2008. Photobiological safety of lamps and lamp systems. IEC62133:2012 2nd ed. Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications. {10}------------------------------------------------ Image /page/10/Picture/2 description: The image shows the logo for Omnilux Clear. The logo features a stylized light burst on the left, followed by the word "OMNILUX" in a serif font. Below "OMNILUX" is the word "CLEAR", with a blue line extending from the left and a red line extending from the right. ISO 10993-1: 2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management. EN ISO 10993-5:2009 Biological Evaluation of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity EN ISO 10993-10:2010 ISO 10993-10 Third Edition 2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization EN 62304: 2006 (ed. 1.0) Medical Device Software - Software Life Cycle Processes. ISO 14971: 2012 Medical Devices - Application of Risk Management to Medical Devices In addition to the aforementioned standards the Omnilux CLEAR labelling was subject to label comprehension testing. With respect to medical devices available without the intervention of a physician, termed 'Over the Counter' (OTC). To determine the effectiveness of labelling pertaining to a medical device, the labelling and device was tested with an appropriate random sample of users. A study was conducted and is appended to this submission, demonstrating comprehension of the Omnilux CLEAR labelling. 27 subjects took part in the study, 14:13 M:F, average age 33.6 years (range 17-65). Six subjects identified English as their second language. In terms of ethnicity two subjects identified as Hispanic, one Native American, one black/African, five Asian, and three Arabic. The average number of words incorrect in the REALM reading test was 5, giving a mean reading ability of 61 (High school) (range 55-66). No new use errors, hazardous situations, or hazard-related use scenarios were discovered during testing. Further improvement of the user interface design as it relates to safety was deemed unnecessary and there were no suggested revisions to the version of the user manual or box packaging tested. The comprehension and use test demonstrated that the Omnilux CLEAR labelling could be used by lay persons to safely and effectively operate the device to attain its intended use and purpose. ## Clinical Performance Since the Omnilux CLEAR mask raises no new questions in terms of safety and efficacy, clinical data is not required. {11}------------------------------------------------ Image /page/11/Picture/2 description: The image shows the logo for Omnilux Clear. The logo features a stylized sunburst graphic to the left of the word "OMNILUX" in a teal sans-serif font. Below "OMNILUX" is the word "CLEAR" in a smaller font, with the left half in blue and the right half in red, separated by a short line. #### Statement of Substantial Equivalence: 513(i) of the FD&C Act (21 U.S.C. 360c(i) states that for substantial equivalence a proposed device is required to have the same intended use and similar technological characteristics as the predicate device. Where there are differences in technological characteristics, these can be negated by appropriate clinical or scientific data demonstrating that the proposed device is as safe and effective as the predicate device, and that the proposed device does not raise any different questions of safety and effectiveness than the predicate device for the same intended use. Globalmed technologies has demonstrated that the Omnilux CLEAR mask has an identical intended use, has the same generic classification and basic principles and technologies as the primary predicate device. Both devices utilize red and blue wavelengths of light with similar power densities and equivalent dose of light. Globalmed Technologies has conducted non-clinical performance testing applicable to those general controls deemed necessary by the agency for this product classification and has determined that the Omnilux CLEAR raises no new questions relating to safety and therefore has demonstrated that the Omnilux CLEAR mask is substantially equivalent to the referenced predicate Acne Light therapy Wand (K160691) June 18th 2021 --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OLP/K210948](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OLP/K210948) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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