(85 days)
Not Found
No
The description focuses on the hardware components, light emission, and safety features. There is no mention of AI, ML, or any related concepts like image processing or data analysis for decision-making.
Yes.
The device is intended to treat medical conditions such as Acne Vulgaris and Melasma, which are therapeutic indications, and to perform hair reduction.
No
The device is described as an "Intense Pulsed Light (IPL) system" intended for "Surgical, Aesthetic applications in Dermatology" to treat conditions like acne, melasma, and for hair reduction. Its function involves using filtered IPL to emit visible ray pulses for therapeutic indications, rather than for diagnosing any condition.
No
The device description explicitly details hardware components such as a Xenon Lamp, Sapphire filters, Main board, LCD screen, Hand-piece, and Cooling system, indicating it is a physical device that utilizes software for control.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for diagnostic or monitoring purposes.
- Device Function: The IDS SHINY IPL system uses Intense Pulsed Light applied directly to the skin for therapeutic purposes (treating acne, melasma, ephelides, and hair reduction). It does not involve the analysis of specimens taken from the body.
- Intended Use: The intended use clearly states "Surgical, Aesthetic applications in Dermatology," which are procedures performed directly on the patient's body.
Therefore, based on the provided information, the IDS SHINY IPL system is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The IDS SHINY IPL system is intended for use in Surgical, Aesthetic and Cosmetic applications in Dermatology by using filtered Intense Pulsed Light to treat the following conditions with different wavelengths to skin types I-IV.
Wavelengths: Conditions:
415nm - 950nm Acne, Vulgaris
560nm - 950nm Melasma, Ephelides
640nm - 950nm Acne, Hair Reduction
640nm - 1200nm Hair Reduction
695nm - 1200nm Hair Reduction
755nm - 1200nm Hair Reduction
Product codes
ONF
Device Description
The SHINY IPL System, using visible rays created by Xenon Lamp through Sapphire which are installed on Hand-piece, and composed Main board, LCD screen, Hand-piece, Cooling system. This device uses computer controlled power supply and filter to generate visible ray pulses of prescribed duration and intensity. This device also equipped the Cooling systems to maintain both the Treatment head / Systems at appropriate and safe temperatures.
The visible ray pulses or emission spectra provide therapeutic indications relevant to specific wavelengths emitted from the system. This system has two hand-pieces and each hand-piece has 3 wavelengths to choose from at the end of the Hand-piece there is a sapphire filter. Visible rays are emitted when the button is pressed.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgical, Aesthetic applications in Dermatology. Prescription Use.
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
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Summary of Performance Studies
The SHINY IPL System performs as intended based on performance data provided in this submission.
Software: Verification and validation testing of the software confirm that the software version is appropriate for release.
Electrical Safety and Electromagnetic Compatibility: The SHINY IPL System has been tested for electromagnetic compatibility and electrical safety per the applicable recognized consensus standards (IEC 60601-1, IEC 60601-1-2).
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.
IDS, Ltd. % Alexander Braun Henderson Official Correspondent BraunSolutions 970 South Dawson Way Unit 14 Aurora, Colorado 80012
October 5, 2018
Re: K181868
Trade/Device Name: SHINY RPL System 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: ONF Dated: July 12, 2018 Received: July 12, 2018
Dear Alexander Braun Henderson:
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.
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
1
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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,
Neil R Ogden -S 2018.10.05 14:13:19 -04'00' ForBinita 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
2
Indications for Use
510(k) Number (if known) K181868
Device Name SHINY RPL System
Indications for Use (Describe)
The IDS SHINY IPL system is intended for use in Surgical, Aesthetic applications in Dermatology by using filtered Intense Pulsed Light to treat the following conditions with different wavelengths to skin types I-IV.
- Wavelengths: Conditions: 415nm - 950nm Acne, Vulgaris 560nm - 950nm Melasma, Ephelides 640nm - 950nm Acne, Hair Reduction 640nm - 1200nm Hair Reduction 695nm - 1200nm Hair Reduction 755nm - 1200nm Hair Reduction
Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY
1. Name of Device:
Trade/Device Name: SHINY IPL System Regulation Number: 21CFR 878.4810 Regulation Description: Laser surgical instrument for use in general and plastic surgery and dermatology. Review Panel: General and Plastic Surgery Device Class: II Product Code: ONF
- K102857 R2PL System, Ahwon Medi Instrument 2. Predicate:
-
- Prior Submissions: There were no prior submissions for the SHINY IPL System.
4. Device Description:
The SHINY IPL System, using visible rays created by Xenon Lamp through Sapphire which are installed on Hand-piece, and composed Main board, LCD screen, Hand-piece, Cooling system. This device uses computer controlled power supply and filter to generate visible ray pulses of prescribed duration and intensity. This device also equipped the Cooling systems to maintain both the Treatment head / Systems at appropriate and safe temperatures.
The visible ray pulses or emission spectra provide therapeutic indications relevant to specific wavelengths emitted from the system. This system has two hand-pieces and each hand-piece has 3 wavelengths to choose from at the end of the Hand-piece there is a sapphire filter. Visible rays are emitted when the button is pressed.
5. Intended Use:
The IDS SHINY IPL system intended for use in Surgical, Aesthetic and Cosmetic applications in Dermatology by using filtered Intense Pulsed Light to treat the following conditions with different wavelengths to skin types I-IV.
| Wavelengths: | Conditions: |
|---|---|
| 415nm - 950nm | Acne, Vulgaris |
| 560nm - 950nm | Melasma, Ephelides |
| 640nm - 950nm | Acne, Hair Reduction |
| 640nm - 1200nm | Hair Reduction |
| 695nm - 1200nm | Hair Reduction |
| 755nm - 1200nm | Hair Reduction |
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6. Comparison to Predicate Device:
| Characteristics | SHINY IPL SYSTEM (IDS LTD.)
Proposed Device | R2PL (Ahwon Medi Instrument)
K102857
Predicate |
|-------------------------|-------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|
| Laser
Wavelengths | 415nm-950nm
560nm-950nm
640nm-950nm
640nm-1200nm
695nm-1200nm
755nm-1200nm | 415nm-950nm
560nm-950nm
590nm-1200nm
640nm-1200nm
695nm-1200nm |
| Lamp Type | Xenon Gas | Xenon Gas |
| Light Type | Intense Pulsed Light | Intense Pulsed Light |
| Light Transfer Method | Hand-piece | Hand-piece |
| Spot Size | 14.3 x 42.6mm | 10.0 x 34.0mm |
| Fluence | 5-40J/cm2 | 5-40J/cm2 |
| Pulse Duration(On Time) | 2.0-35.0ms | 2.0-35.0ms |
| Pulse Delay(Off Time) | 3.0-60.0ms | 3.0-60.0ms |
| Repetition Rate | 1, 3, 5Hz | 1Hz |
7. Summary of Performance and Safety Testing:
The SHINY IPL System performs as intended based on performance data provided in this submission.
Software: Verification and validation testing of the software confirm that the software version is appropriate for release.
Electrical Safety and Electromagnetic Compatibility: The SHINY IPL System has been tested for electromagnetic compatibility and electrical safety per the applicable recognized consensus standards (IEC 60601-1, IEC 60601-1-2).
8. Conclusion:
The SHINY IPL System was found to be substantially equivalent to the predicate devices and shares the same or similar indications for use, design, operational features as the predicate devices.