Silicon flexible face mask
Controller
Power supply and country specific adaptors
USB C to USB A connector
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 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.

AI/ML Overview

The provided document is a 510(k) premarket notification for the Omnilux CLEAR device, intended for treating mild to moderate acne vulgaris. It focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing a clinical study with acceptance criteria and performance data in the typical sense of a comparative effectiveness study for an AI/ML algorithm.

Therefore, many of the requested details about acceptance criteria, ground truth establishment, expert adjudication, MRMC studies, and standalone performance for an AI/ML device are not present in this document because it describes a light therapy device, not an AI/ML system.

However, I can extract information related to the device's performance based on the provided text, particularly concerning its comparison to predicate devices and the non-clinical testing performed.

Here's an analysis of the provided text in the context of your request:

1. A table of acceptance criteria and the reported device performance

The document does not present "acceptance criteria" for clinical performance in the way an AI/ML algorithm might (e.g., target specificity, sensitivity, or AUC threshold). Instead, it demonstrates substantial equivalence to predicate devices by comparing technological characteristics and intended use. The "performance" is implicitly tied to meeting similar specifications as the predicates and demonstrating general safety and functionality through non-clinical testing.

Here's a table summarizing the device's characteristics compared to predicates, which are implicitly its performance against established acceptable characteristics for such devices:

Characteristic	Acceptance Criteria (Predicate K160691)	Reported Device Performance (Omnilux CLEAR)	Remarks
Intended Use	Treat mild to moderate acne vulgaris	Treat mild to moderate acne vulgaris	Identical
Device Classification	Class II	Class II	Identical
Product Code	OLP	OLP	Identical
Energy Type	Light emitting diodes	Light emitting diodes	Identical
Peak Wavelength (Red)	633 ± 4nm	630nm +/- 5nm	Equivalent
Peak Wavelength (Blue)	442 ± 4nm	412.5nm +/- 7.5nm	Equivalent
Intensity (Blue)	26.5 mW/cm²	28 mW/cm²	Equivalent
Intensity (Red)	7.5 mW/cm²	16 mW/cm²	Equivalent
Total Intensity	34 mW/cm²	44 mW/cm²	Equivalent
Treatment Time	6 minutes	10 minutes	Equivalent
Dose (Blue)	9.6 J/cm²	16.8 J/cm²	Equivalent
Dose (Red)	2.6 J/cm²	9.6 J/cm²	Equivalent
Treatment Protocol (Freq.)	Daily	4 x weekly, 6 weeks	Similar (Differences are acceptable for light therapy devices)

The justification for "equivalence" in parameters like wavelength, intensity, treatment time, and dose is that these differences "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." In this case, the document argues that the non-clinical testing (electrical safety, EMC, photobiological safety, biocompatibility, software, risk management) addresses these differences, implying no new safety/efficacy concerns.

2. Sample size used for the test set and the data provenance

For the device itself (Omnilux CLEAR, a light therapy mask), there isn't a "test set" in the sense of a dataset of images/cases for an AI algorithm.

However, there was a label comprehension testing study, which can be considered a form of human factors "test set":

Sample Size: 27 subjects
Data Provenance: Not explicitly stated, but the study implies it was conducted with participants, presumably in a controlled environment. Retrospective/Prospective is not specified but usually, such studies are prospective. Country of origin not specified, but the submission is to the US FDA.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This is not applicable in the context of this 510(k) submission for a light therapy device. There was no medical "ground truth" to establish for a diagnostic AI system's performance.

For the label comprehension study:

There were no "experts" establishing a ground truth in the medical sense. The "ground truth" for label comprehension was the correct understanding of the device's labeling by lay users, assessed against pre-defined correct answers to comprehension questions. The study assessed user comprehension, not medical ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable for this type of device. No medical adjudication was performed as there was no diagnostic "test set" requiring it.

For the label comprehension study:

No adjudication method like 2+1 was described. The study likely involved participants answering comprehension questions based on the labeling, and their answers were scored against a pre-determined correct set.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI systems in diagnostic imaging, not for a light therapy device. The document explicitly states: "Since the Omnilux CLEAR mask raises no new questions in terms of safety and efficacy, clinical data is not required." This means no human-in-the-loop or clinical efficacy study was required for this 510(k) clearance due to the device's substantial equivalence to predicates.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI/ML algorithm. It is a physical light therapy device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable for the device's therapeutic function, as clinical data was not required.

For the label comprehension study, the "ground truth" was simply the intended meaning and safe usage instructions contained within the device's labeling.

8. The sample size for the training set

Not applicable. This refers to AI/ML algorithms. The Omnilux CLEAR is a hardware device.

9. How the ground truth for the training set was established

Not applicable. This refers to AI/ML algorithms.

Summary of what was presented in the document:

The submission focuses heavily on demonstrating substantial equivalence of the Omnilux CLEAR to predicate light therapy devices (K160691 and K081307) based on:

Identical intended use.
Similar technological characteristics (energy type, wavelengths, intensities, doses, treatment times).
Compliance with relevant non-clinical performance and safety standards (electrical safety, EMC, photobiological safety, biocompatibility, software life cycle, risk management).
Label comprehension testing to ensure lay users can operate the device safely and effectively without professional medical intervention.

The document argues that because the Omnilux CLEAR is substantially equivalent to existing devices and presents no new questions of safety or efficacy, a full clinical study with human patients for therapeutic effectiveness was not required for its 510(k) clearance.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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.

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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 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

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Indications for Use

510(k) Number (if known) K210948

Device Name Omnilux CLEAR

Indications for Use (Describe)

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)

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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:

RegulationNumber	Device Classificationname	DeviceClass	ProductCode	ClassificationPanel	Type
21 CFR 878.4810Laser surgicalinstrument for usein general andplastic surgery andin dermatology.	Over-The-CounterPowered Light-BasedLaser For Acne	Class 2	OLP	General &Plastic Surgery	Traditional510 (k)

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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.
1. Controller
1. Power supply and country specific adaptors
1. 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.

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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

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.

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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	K160691Acne Light TherapyWand	K081307Omnilux CLEAR-U	Significantdifferences
Device Manufacturer	Globalmed Technologies	Zuko, Inc	Photo Therapeutics Inc.	na
Device Trade Name	Omnilux CLEAR™	Acne Light TherapyWand	Omnilux CLEAR-UTM	na
510(K) Number	-	K160691	K081307	na
Device Common Name	Omnilux CLEAR	Acne Light TherapySystem	Omnilux CLEAR-U	na
Device Classification name	Over-The-CounterPowered Light-BasedLaser for Acne	Over-The-CounterPowered Light-BasedLaser for Acne	Light Based Over theCounter Acne Reduction	Identical
Device Product Code	OLP	OLP	OLP	Identical
Regulation Number	878.4810Laser surgical instrumentfor use in general andplastic surgery and indermatology.	878.4810Laser surgicalinstrument for use ingeneral and plasticsurgery and indermatology.	878.4810Laser surgicalinstrument for use ingeneral and plasticsurgery and indermatology.	Identical
Description	Omnilux CLEAR	K160691Acne Light TherapyWand	K081307Omnilux CLEAR-U	Significantdifferences
FDA Device Classification	Class II	Class II	Class II	Identical
Use	Over the Counter	Over the Counter	Over the Counter	Identical
Intended use andIndications	The Omnilux CLEARacne facemask is an over-the-counter deviceintended to emit energy inthe red and blue region ofthe light spectrum,specifically indicated totreat mild to moderateacne vulgaris on the face.	The Acne Light TherapyWand is an over-the-counter device that usesa combination of bluelight and red light and isindicated to treat mild tomoderate inflammatoryacne	The Omnilux CLEAR-Uis an over-the-counterdevice that is intendedfor the use in thetreatment of mild tomoderate 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 ± 4nmBlue: 442 ± 4nm	Red: 633nm +/- 6nmBlue:415nm +/ 5nm	Equivalent
Intensity (mW/cm²)	Blue 28 mw/cm²Red 16 mw/cm²	Blue 26.5 mw/cm²Red 7.5 mw/cm²	Blue 40mw/cm2Red 70mw/cm2	Equivalent
Total Intensity (mW/cm²)	44mw/cm²	34mw/cm²	110 mw/cm²	Equivalent
Description	Omnilux CLEAR	K160691Acne Light TherapyWand	K081307Omnilux CLEAR-U	Significantdifferences
Treatment time	10 Minutes	6 minutes1	20 minutes	Equivalent
Dose	Blue 16.8J/cm2Red 9.6J/cm2	Blue 9.6J/cm2Red 2.6J/cm2	Blue 24J/cm2Red 42J/cm2	Equivalent
Treatment protocol(Treatment time)	4 x weekly, 6 weeks	Daily	2 x weekly, 4 weeks	Similar
Timers	Device uses a timer andsoftware to controltreatment duration.	Device uses a timer andsoftware to controltreatment duration.	Device uses a timer andsoftware to controltreatment duration	Identical
Software Controlled	Yes	Yes	Yes	Identical

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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.

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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.

Mathematically derived

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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.

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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.

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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

Regulation Number and Section

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.