(64 days)
The Iluminage Skin Smoothing Laser is indicated for use in the treatment of periorbital and perioral wrinkles.
The Iluminage Skin Smoothing Laser is a battery powered, home use (OTC) diode laser. The device emits continuous wave diode laser energy for a specified period of time to a fixed area of skin. This energy triggers the body's natural response to generate new collagen, which helps tighten the skin which reduces wrinkles.
The device is composed of a handpiece for delivery of laser energy, base unit for charging and storage when not in use, an A.C. charging adapter, Instructions for Use, USB data cable and carrying pouch. The handpiece contains a 1440nm laser diode light source, internal energy power source and control electronics with embedded software. The device has been modified to add user convenience features.
The provided document is a 510(k) summary for the Iluminage Skin Smoothing Laser. It focuses on demonstrating substantial equivalence to a predicate device, the Cynosure Iluminage Diode Laser (K111454), rather than providing detailed acceptance criteria and a study to prove they are met in the manner typically seen for new algorithm-based medical devices.
The modifications to the device primarily involve user convenience features and do not change the indications for use or the core technological characteristics (wavelength, fluence, spot size, repetition rate). Therefore, the "acceptance criteria" and "study" described are focused on verifying that these modifications function correctly and do not negatively impact the device's performance, which is assumed to be equivalent to the predicate.
Here's the information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of "acceptance criteria" with numerical targets and reported performance for the Iluminage Skin Smoothing Laser as a new, standalone device to treat wrinkles. Instead, it demonstrates through testing that modifications to the device were correctly implemented and that the device performs the same as the predicate device. The "acceptance criteria" can be inferred from the nature of the modifications and the non-clinical tests performed.
| Acceptance Criterion (Inferred from non-clinical tests) | Reported Device Performance |
|---|---|
| Correct Implementation of Revised Arming Sequence | The testing confirmed that the revised arming sequence was correctly implemented and the laser would function when followed. |
| Ability to Change Treatment Levels | The testing confirmed that treatment levels could be changed. |
| Functionality of Indicators (Skin Contact, Battery Status, Treatment Count, High Temp) | The testing confirmed that indicators such as skin contact, battery status, treatment count, and high-temperature limits would function. |
| Data Acquisition Functionality | The testing confirmed that data acquisition could be performed (a new feature for the modified device). |
| Overall Performance Equivalence to Predicate Device | "Testing confirmed that the performance of the Iluminage Skin Smoothing Laser meets the product system requirements, which is based on the predicate device. Therefore, the modification resulted in a device that performs the same as the predicate device." The technological characteristics (Wavelength, Fluence, Spot Size, Rep. Rate) are identical to the predicate device, suggesting equivalent fundamental performance. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document describes non-clinical software verification testing. This typically involves internal hardware/software testing and verification by the manufacturer, not a clinical "test set" with patient data in the sense of an algorithm.
- Sample Size: Not specified in terms of patient data. The "test set" refers to verification procedures performed on the device itself.
- Data Provenance: Not applicable in the context of patient data. This was internal device verification.
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 the evaluation was not based on expert-established ground truth for patient data or an algorithm's output. It was a device functionality and performance verification against its own design specifications and equivalence to a predicate.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as the evaluation was a device functionality and performance verification, not a clinical study involving human readers or interpretation of results that would require adjudication.
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 MRMC study was done. This device is a direct-to-consumer laser for wrinkle reduction; it does not involve human readers' interpretation of images or AI assistance. The study described is a non-clinical verification of device modifications.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No standalone algorithm performance study was done. This is a physical laser device, not an algorithm. The "software verification" was for the embedded control software.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the non-clinical tests was the expected functional behavior and performance defined by the device's design specifications and its equivalence to the predicate device. For example, the "ground truth" for the arming sequence test was that the laser should function when the proper sequence is followed.
8. The sample size for the training set
Not Applicable. This is a hardware device with embedded control software, not a machine learning model that requires a "training set."
9. How the ground truth for the training set was established
Not Applicable. As mentioned above, there is no "training set."
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JAN 15 2014
.
Section 6: 510(k) Summary
This 510(k) Summary information is submitted in accordance with the requirements of 21 C.F.R. 807.92.
| 807.92(a)(1) - Submitter Information | |
|---|---|
| Name | Cynosure Inc. |
| Address | 5 Carlisle RoadWestford, MA 01886 |
| Phone number | 978-367-8736 |
| Fax number | 978-256-6556 |
| EstablishmentRegistration Number | 1222993 |
| Name of contact person | Kevin J. O'Connell |
| Date prepared | January 15, 2014 |
| 807.92(a)(2) - Name of device | |
| Trade or proprietary name | Iluminage Skin Smoothing Laser |
| Common or usual name | Medical Laser System |
| Classification name | Light Based Over the Counter Wrinkle Reduction |
| Classification panel | General and Plastic Surgery |
| Regulation | 878.4810 |
| Product Code(s) | OHS |
| 807.92(a)(3) - Legally marketed device(s) to which equivalence is claimed | |
| Cynosure Iluminage Diode Laser, K111454 | |
| 807.92(a)(4) - Device description | |
| The Iluminage Skin Smoothing Laser is a battery powered, home use (OTC) diode laser. The device emits continuous wave diode laser energy for a specified period of time to a fixed area of skin. This energy triggers the body's natural response to generate new collagen, which helps tighten the skin which reduces wrinkles.The device is composed of a handpiece for delivery of laser energy, base unit for charging and storage when not in use, an A.C. charging adapter, Instructions for Use, USB data cable and carrying pouch. The handpiece contains a 1440nm laser diode light source, internal energy power source and control electronics with embedded software. The device has been modified to add user convenience features. |
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| Indications for use | The Iluminage Skin Smoothing Laser is indicated for use in the treatment ofperiorbital and perioral wrinkles. | ||
|---|---|---|---|
| The modifications to the device have not changed the indications for use forthe device. | |||
| 807.92(a)(6) Summary of the technological characteristics of the device compared to the predicate | |||
| Characteristic | Iluminage Diode Laser | Iluminage Skin Smoothing Laser | |
| Device Type | Diode Laser | Diode Laser | |
| Wavelenght(nm) | 1440 | 1440 | |
| Fluence (J/cm²) | 3-4 | 3-4 | |
| Spot Size (mm) | 7 | 7 | |
| Rep. Rate | 1 | 1 | |
| Data acquisition | No | Yes | |
| Handpiececharging method | In base unit | In base unit ordirect connection to USB cable or powercord | |
| Skin ContactIndicator Color | Blue | White | |
| EnergyDeliveredIndicator Color | White | Blue | |
| Armingsequence | Short, short, long button presses | One long press of 3-5 seconds | |
| 807.92(b)(1-2) Nonclinical tests submitted | |||
| Test | Result | ||
| Iluminage Software Verification | The testing confirmed that modifications made to the devicewere correctly implemented. This included operating the deviceto insure: when the revised arming sequence is followed the laserwould function; treatment levels can be changed; indicators suchas skin contact, battery status, treatment count and hightemperature limits would function; and that data acquisitioncould be performed. | ||
| 807.92(b)(3) Conclusions drawn from non-clinical data | |||
| Testing confirmed that the performance of the Iluminage Skin Smoothing Laser meets the product systemrequirements, which is based on the predicate device. Therefore, the modification resulted in a device thatperforms the same as the predicate device. |
·
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Cynosure Incorporated Mr. Kevin J. O'Connell Manager Regulatory Affairs 5 Carlise Road Westford, Massachusetts 018886
January 15, 2014
Re: K133473
Trade/Device Name: Cynosure Iluminage Skin Smoothing Laser 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: OHS Dated: December 16, 2013 Received: December 17, 2013
Dear Mr. O'Connell:
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Mr. Kevin J. O'Connell
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Joshua C. Nipper -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director For 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): K133473
Device Name: Cynosure Iluminage Skin Smoothing Laser
Indications For use: The Iluminage Skin Smoothing Laser is indicated for use in the treatment of periorbital and perioral wrinkles.
PRESCRIPTION USE _ (Part 21 CFR 801 Subpart D)
AND/OR Over-The-Counter Use X (21 CFR 801 Subpart C).
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil R Ogden S
2014.01.14 09:47:55 -05'00'
(Division Sign-Off) for BSA
Division of Surgical Devices
510(k) Number_K133473
§ 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.