(64 days)
Not Found
No
The summary describes a laser device with embedded software for control and user convenience features, but there is no mention of AI or ML capabilities.
Yes
The device is indicated for the treatment of periorbital and perioral wrinkles, which is a therapeutic use.
No
The device is indicated for treatment of wrinkles by generating new collagen, which is a therapeutic rather than diagnostic function.
No
The device description explicitly states it is a battery-powered, home-use diode laser with a handpiece containing a laser diode light source, internal energy power source, and control electronics with embedded software. This indicates significant hardware components beyond just software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Iluminage Skin Smoothing Laser is a therapeutic device that uses laser energy applied externally to the skin to treat wrinkles. It does not analyze any samples taken from the body.
- Intended Use: The intended use is for the treatment of wrinkles, which is a therapeutic application, not a diagnostic one.
The description clearly indicates it's a home-use laser device for skin treatment, not for analyzing biological samples.
N/A
Intended Use / Indications for Use
The Iluminage Skin Smoothing Laser is indicated for use in the treatment of periorbital and perioral wrinkles.
Product codes (comma separated list FDA assigned to the subject device)
OHS
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
periorbital and perioral wrinkles
Indicated Patient Age Range
Not Found
Intended User / Care Setting
home use (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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Test: Iluminage Software Verification
Result: The testing confirmed that modifications made to the device were correctly implemented. This included operating the device to insure: when the revised arming sequence is followed the laser would function; treatment levels can be changed; indicators such as skin contact, battery status, treatment count and high temperature limits would function; and that data acquisition could be performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
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 Road |
| Westford, MA 01886 | |
| Phone number | 978-367-8736 |
| Fax number | 978-256-6556 |
| Establishment | |
| Registration 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. | |
1
| Indications for use | | The Iluminage Skin Smoothing Laser is indicated for use in the treatment of
periorbital and perioral wrinkles. | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|
| | | The modifications to the device have not changed the indications for use for
the 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 |
| Handpiece
charging method | | In base unit | In base unit or
direct connection to USB cable or power
cord |
| Skin Contact
Indicator Color | | Blue | White |
| Energy
Delivered
Indicator Color | | White | Blue |
| Arming
sequence | | 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 device
were correctly implemented. This included operating the device
to insure: when the revised arming sequence is followed the laser
would function; treatment levels can be changed; indicators such
as skin contact, battery status, treatment count and high
temperature limits would function; and that data acquisition
could 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 system
requirements, which is based on the predicate device. Therefore, the modification resulted in a device that
performs the same as the predicate device. | | | |
·
2
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
3
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
4
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