(407 days)
Not Found
No
The summary does not mention AI, ML, image processing, or any data sets typically associated with AI/ML model training or testing. The device description is purely hardware-based.
Yes
The device is indicated for the treatment of periorbital and perioral wrinkles, which clearly describes a therapeutic function.
No
The device is indicated for treatment (treatment of periorbital and perioral wrinkles), not for diagnosis.
No
The device description explicitly states it is a diode laser composed of a handpiece, base unit, and charger unit, indicating it is a hardware device.
Based on the provided information, the Iluminage laser device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the treatment of periorbital and perioral wrinkles. This is a therapeutic use, not a diagnostic one.
- Device Description: The description details a laser device used for treatment, not for analyzing samples from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests on these samples, or providing diagnostic information.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Iluminage device's function is to deliver laser energy to the skin for therapeutic effect.
N/A
Intended Use / Indications for Use
The Iluminage Diode Laser is indicated for use in the treatment of periorbital and perioral wrinkles.
Product codes
79-GEX, OHS
Device Description
Iluminage is a diode laser composed of a handpiece, base unit and a charger unit.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
periorbital and perioral
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Nonclinical Performance Data: none Clinical Performance Data: none
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K111454, Cynosure Affirm DO Diode Laser
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.
0
III 454
510(K) Summary
5 2012 JUL
Cynosure, Inc. 5 Carlisle Road Westford, MA 01886
George Cho Sr. VP of Medical Technology and Regulatory Affairs
May 24, 2011
Iluminage Diode Laser
Medical Laser System
Instrument, Surgical, Powered, Laser 79-GEX 21 CFR 878.4810
Cynosure Affirm DO Diode Laser
Iluminage is a diode laser composed of a handpiece, base unit and a charger unit.
The Iluminage Diode Laser is indicated for use in the treatment of periorbital and perioral wrinkles.
The Iluminage Diode laser has the same indications for use, the same principle of operation, the same wavelength and the same technology as the predicate devices.
Nonclinical Performance Data: none Clinical Performance Data: none Conclusion:
Additional Information:
The Iluminage Diode laser is a safe and effective device for the intended uses.
none
Submitter:
Contact:
Date Summary Prepared: Device Trade Name: Common Name:
Classification Name:
Equivalent Device: Device Description:
Intended Use:
Comparison:
sification Name:
Equivalent Device:
Device Description:
Intended Use:
Comparison:
parison:
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three swooping lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
5 2012
JUL
Cynosure, Incorporated % Mr. George Cho Senior Vice President of Medical Technology and Regulatory Affairs 5 Carlisle Road Westford, Massachusetts 01886
Re: K111454
Trade/Device Name: Iluminage Diode Laser Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology
Regulatory Class: II Product Code: OHS, GEX Dated: June 29, 2012 Received: July 02, 2012
Dear Mr. Cho:
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.
2
Page 2 -- Mr. George Cho
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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark N. Melker Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): K 111454
Device Name: Iluminage Laser
Indications For Use: The Iluminage laser device is indicated for use in the treatment of periorbital and perioral wrinkles.
Prescription Use (Part 21 CFR 801 Subpart D)
.
OR
Over-The-Counter Use X (Part 21 CFR 80) Subpart C)
(PLE.ASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil RPDsden for mkm
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
. 510(k) Number K 111454