The SAPPHIRE is an over -the -counter hand held, battery operated, light therapy device that uses light emitting diodes (LEDs) that emit a specific wavelength of 415nm (Blue Light) that is intended for use in the treatment of mild to moderate inflammatory acne.

Device Description

The Sapphire device is an over-the-counter, battery powered, hand-held device that emits light energy in the blue spectrum for the treatment of mild to moderate inflammatory acne by emitting 50 mW/cm² of blue (415 nm +/- 5nm) light via an electric light emitting diode [LEDs] energy source. The Sapphire device operates by a cordless system drawing upon its rechargeable Li-Ion batteries to deliver the treatment. The unit is applied directly to the skin to ensure consistent administration of light during each treatment. There are no user settings or adjustments required. The device does not contain any user serviceable components. The device is sold as Over the Counter (OTC).

AI/ML Overview

The provided text describes the Sapphire device, an over-the-counter hand-held, battery-operated light therapy device that uses LEDs emitting 415nm (Blue Light) for treating mild to moderate inflammatory acne. The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving specific performance metrics against acceptance criteria in a clinical study.

Here's a breakdown of the requested information based on the provided text:

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

The provided text does not explicitly state specific quantitative acceptance criteria or a direct comparison of the Sapphire device's performance against such criteria in a clinical efficacy study. Instead, it focuses on demonstrating substantial equivalence to predicate devices based on shared technological characteristics and intended use. The "performance" described is in terms of safety and technical conformance.

Feature/Standard	Acceptance Criteria (Implicit from Predicate Equivalence)	Reported Device Performance
Intended Use	Treatment of mild to moderate inflammatory acne	Same as predicate
Output (Energy Level)	50 mW/cm²	50 mW/cm²
Wavelength	415 nm +/- specified range (e.g., 6nm or 15nm)	415 nm +/- 5nm
Total Energy Delivered per Treatment	9-12 J/cm²	12 J/cm²
Treatment Time	3-4 minutes per area, or 4 minutes per area twice per week for 4 weeks	4 minutes per area, twice per week for 4 weeks (total of 8 treatments)
Handheld	Yes	Yes
Location for Use	Over-the-Counter (OTC)	OTC
Modes	On/Off	On/Off
Electrical Safety (IEC60601-1)	Conformance to standard	Conforms
EMC (IEC 60601-1-2)	Conformance to standard	Conforms
Battery Safety (IEC 62133)	Conformance to standard	Conforms
Home Healthcare Environment (IEC 60601-1-11)	Conformance to standard	Conforms
Photobiological Safety (IEC 62471)	Conformance to standard	Conforms
Biocompatibility (ISO 10993-1, -5, -10)	Conformance to standards	Conforms
Software Validation	Conformance to FDA guidance	Software was tested and validated
Usability/Label Comprehension	High percentage of participants able to comprehend labeling and use device successfully	96% comprehended labeling, 96% used device successfully

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Usability/Label Comprehension Study: 35 participants.
Data Provenance: The document does not specify the country of origin for the usability study. It is implied to be a prospective study as participants "were able to comprehend" and "were able to use," suggesting active participation during the study.
For Efficacy: The document does not report a clinical efficacy study for the Sapphire device; instead, it relies on substantial equivalence to predicate devices. Therefore, there is no sample size for an efficacy test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable as no clinical efficacy study with a ground truth established by experts is reported for the Sapphire device. The "test set" mentioned applies to the usability/label comprehension study, which doesn't involve medical experts establishing a "ground truth" in the clinical sense.

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

This information is not applicable as no clinical efficacy study requiring adjudication of findings is reported. The usability study would likely involve direct observation or survey responses, not an adjudication process.

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

This information is not applicable. The Sapphire device is a light therapy device, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC comparative effectiveness study comparing human readers with and without AI assistance is irrelevant to this device.

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

This information is not applicable. The Sapphire device is a physical light therapy device, not a standalone algorithm.

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

This information is not applicable for a clinical efficacy study, as such a study is not reported. For the usability study, the "ground truth" would be the observed ability of participants to understand the labeling and operate the device successfully.

8. The sample size for the training set

This information is not applicable as no clinical efficacy study requiring a training set for an algorithm is reported for the Sapphire device.

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

This information is not applicable as no clinical efficacy study requiring a training set is reported.

Summary

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May 1, 2018

Omm Imports, Inc. d/b/a Zero Gravity % Ms. Susan Anthoney-Dewet Aegis, Inc 2424 Dempster Drive Coralville, Iowa 52241

Re: K172555

Trade/Device Name: Sapphire, Elevare Sapphire 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: April 19, 2018 Received: April 20, 2018

Dear Ms. Anthoney-Dewet:

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. 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.

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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820);

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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely. Jennifer R. Stevenson -ਟਤ

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K172555

Device Name SAPPHIRE

Indications for Use (Describe)

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(k) Summary

K172555

This summary of 510(k) summary information is being submitted in accordance with the requirements of 21 CFR § 807.92

Submission Date: August 23, 2017

1. Submitter Information:	AEGIS Regulatory, Inc. – Susan Anthoney-DeWet
	2424 Dempster Drive
	Coralville, IA 52241
	Tel.: 865-982-5552
	Email: sue@fdalistingconsultants.com

On behalf of Sponsor:	Omm Imports, Inc. d/b/a Zero Gravity
	Attn: Moti Shenfarber
	9737 NW 41st Street STE 234
	Doral, FL 33178
	Email: moti@zerogravityskin.com

2. General Information

2.1 Classification Name: Light Based Over-The-Counter Powered Light Based Laser For Acne
2.2 Common/Usual Name: Blue Light Therapy for Acne
2.3 Proprietary Names: Sapphire
2.4 Classification: Class II
2.5 Classification Number: 878.4810

2.6 Product Code: OLP

3. Predicate Device(s):

Primary Predicate Device: K121435 – Silk'n Blue (Home Skinovations LTD)

Secondary Predicate Device: K131461 – LightStim for Acne Mini (LED Intellectual Properties LLC)

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4. Device Description:

5. Indications / Intended Use:

The SAPPHIRE is an over –the -counter hand held, battery operated, light therapy device that uses light emitting diodes (LEDs) that emit a specific wavelength of 415nm (Blue Light) that is intended for use in the treatment of mild to moderate inflammatory acne.

6. Technological Characteristics & Substantial Equivalency:

Summary of the technological characteristics of the device compared to predicate device:

Device	Silk 'N Blue	LightStim for Acne Mini	Sapphire
	Home Skinovations,LTD.K121435A Predicate Device	LED IntellectualProperties, LLCK131461A Predicate Device	Zero Gravity, LLCK172555This Submission
Indications	The Silkn Blue isindicated as an overthe counterphototherapy devicefor the treatment ofmild to moderate acne	LightStim for AcneMini is an over-the-counter, hand helddevice intended for theuse in the treatment ofmild to moderate acne.	The SAPPHIRE is anover -the -counterhand held, batteryoperated, light therapydevice that uses lightemitting diodes(LEDs) that emit aspecific wavelength of415nm (Blue Light)that is intended for usein the treatment ofmild tomoderateinflammatory acne.
Handheld	Yes	Yes	Yes
Wavelength	415 nm +/- 15nm	415 nm +/- 6nm	415 nm +/- 5nm

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Device	Silk 'N Blue	LightStim for Acne Mini	Sapphire
	Home Skinovations,LTD.	LED IntellectualProperties, LLC	Zero Gravity, LLC
	K121435	K131461	K172555
	A Predicate Device	A Predicate Device	This Submission
Modes	On/Off	On/Off	On/Off
Energy Level	50 mW/cm2	50 mW/cm2	50 mW/cm2
TreatmentTime	4 minutes per area, twiceper week for 4 weeks(total of 8 treatments)	3-4 minutes per area	4 minutes per area, twiceper week for 4 weeks(total of 8 treatments)
Total Energydelivered perTx	12 J/cm2	9-12 J/cm2	12 J/cm2
Location forUse	OTC	OTC	OTC

Has the same intended use as the predicate(s) (i.e., Treatment of mild to moderate inflammatory acne ;
Has the same output (i.e., 50 mW/cm2 ) as the predicate(s);
Utilizes the same wavelength (i.e., 415 nm +/- 5nm) as the predicate device(s);
Utilizes the same standard dose (i.e., 121/cm2) as the predicate device(s);

The Sapphire device and the above referenced predicate devices are Over the Counter devices used to treat mild to moderate inflammatory acne as defined in 21 CFR § 878.4810. These devices utilize blue diodes at 415nm to provide narrow bands of light energy to treat mild to moderate inflammatory acne vulgaris. The performance achieved by these devices is similar with equal power output. The devices are handheld, and intended to be placed directly on the skin. They are manufactured out of similar materials. Based upon comparison to the predicate device, the Sapphire device has the same intended use, with similar technological characteristics as the predicate device. The system performs as intended and does not raise any new safety or effectiveness issues.

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7. Performance Data/Non-Clinical Testing:

Testing of the Sapphire device included safety testing to various international standards, bench testing--functional performance testing (power output), software validation testing and user safety testing.

The results of this testing are as follows:

Conforms to international consensus standards:

ELECTRICAL SAFETY: Recognition Number 19-4:

IEC60601-1 Medical Electrical Equipment Part 1: General Requirements For Basic ● Safety And Essential Performance

EMC:

Recognition Number 19-8:

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

BATTERY SAFETY:

Recognition Number 19-13:

IEC 62133;2013: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

HOME HEALTHCARE ENVIRONMENT:

Recognition Number 19-14:

IEC 60601-1-11 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 Home Healthcare Environment

LAMP SAFETY:

Recognition Number 12-249:

IEC 62471 First Edition 2006-07, Photobiological Safety Of Lamps And Lamp Systems. (Radiology)

BIOCOMPATIBILITY:

Recognition Number 2-156:

o ISO 10993-1:2009/(R) 2013. Biological Evaluation Of Medical Devices -- Part 1: Evaluation And Testing Within A Risk Management Process.

Recognition Number 2-153:

ISO 10993-5:2009/(R) 2014, Biological Evaluation Of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity.

Recognition Number 2-174:

ISO 10993-10 Third Edition 2010-08-01, Biological Evaluation Of Medical Devices -● Part 10: Tests For Irritation And Skin Sensitization.

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The Sapphire device's software was tested and validated in accordance with FDA's "Guidance for the content of Premarket Submissions for Software Contained in Medical Devices."

A Usability/Label Comprehension Study was conducted with 35 participants. The results of the study found that: 96% of the participants were able to comprehend the labeling. 96% of the participants were able to use the device successfully.

User Safety testing reflects device can be used in a safe and effective manner.

9. Substantial Equivalence Conclusion

After an analysis of the safety, indications, intended uses, performance, design materials, power output, technological properties, treatment areas, and treatment regimes the manufacturer believes that no significant differences exist between the device and the predicate device. Therefore substantial equivalency is requested.

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.