(250 days)
No
The device description and performance studies focus solely on light therapy and hardware functionality, with no mention of AI/ML algorithms or data processing.
Yes
The device is intended for the "treatment of mild to moderate inflammatory acne," which indicates a therapeutic purpose.
No
This device is intended for the treatment of mild to moderate inflammatory acne, not for diagnosis.
No
The device description explicitly states it is a "hand held, battery operated, light therapy device" that uses "light emitting diodes (LEDs)" and is "applied directly to the skin," indicating it is a physical hardware device. While it mentions "software validation testing," this is likely for controlling the hardware, not the primary function of the device being software-based.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "treatment of mild to moderate inflammatory acne" using light therapy applied directly to the skin. This is a therapeutic application, not a diagnostic one.
- Device Description: The device is a hand-held light therapy device that emits blue light. It is applied to the skin for treatment.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze biological samples (like blood, urine, tissue, etc.) or to provide information about a patient's health status or condition based on such analysis. IVDs are specifically designed for these purposes.
In summary, the Sapphire device is a therapeutic device for treating acne, not a diagnostic device for identifying or characterizing a disease or condition.
N/A
Intended Use / Indications for 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.
Product codes
OLP
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).
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
Over the Counter (OTC)
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
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: IEC60601-1 Medical Electrical Equipment Part 1: General Requirements For Basic Safety And Essential Performance
EMC: 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: 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: 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: IEC 62471 First Edition 2006-07, Photobiological Safety Of Lamps And Lamp Systems. (Radiology)
BIOCOMPATIBILITY: ISO 10993-1:2009/(R) 2013. Biological Evaluation Of Medical Devices -- Part 1: Evaluation And Testing Within A Risk Management Process.
ISO 10993-5:2009/(R) 2014, 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.
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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.
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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.
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)
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.
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)
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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:
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).
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. | |||
| K121435 | |||
| A Predicate Device | LED Intellectual | ||
| Properties, LLC | |||
| K131461 | |||
| A Predicate Device | Zero Gravity, LLC | ||
| K172555 | |||
| This Submission | |||
| Indications | The Silkn Blue is | ||
| indicated as an over | |||
| the counter | |||
| phototherapy device | |||
| for the treatment of | |||
| mild to moderate acne | LightStim for Acne | ||
| Mini is an over-the- | |||
| counter, hand held | |||
| device intended for the | |||
| use in the treatment of | |||
| mild to moderate acne. | 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. | |||
| 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 Intellectual | ||
| Properties, 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 |
| Treatment | |||
| Time | 4 minutes per area, twice | ||
| per week for 4 weeks | |||
| (total of 8 treatments) | 3-4 minutes per area | 4 minutes per area, twice | |
| per week for 4 weeks | |||
| (total of 8 treatments) | |||
| Total Energy | |||
| delivered per | |||
| Tx | 12 J/cm2 | 9-12 J/cm2 | 12 J/cm2 |
| Location for | |||
| Use | 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.
7
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.