(127 days)
Not Found
No
The summary describes a laser device for therapeutic heating and does not mention any AI or ML components or functionalities.
Yes
The device is described as providing "heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and/or the temporary relaxation of muscle," which are therapeutic effects.
No
The "Intended Use / Indications for Use" section clearly states that the device is intended for therapeutic purposes (heating for pain relief, increased circulation, muscle relaxation), not for diagnosing medical conditions.
No
The device description explicitly states it is a "laser device" and a "compact diode laser system," indicating it is a hardware device that delivers laser energy.
Based on the provided information, the Cynosure 1064nm Diode Laser Device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for providing heating to elevate tissue temperature for therapeutic purposes (pain relief, increased blood circulation, muscle relaxation). This is a direct treatment applied to the body.
- Device Description: The description details a laser device that delivers energy to tissue. This is an external application of energy, not a test performed on a sample taken from the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
Therefore, the Cynosure 1064nm Diode Laser Device falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Cynosure 1064nm Diode Laser Device is intended to provide heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and/or the temporary relaxation of muscle.
Product codes (comma separated list FDA assigned to the subject device)
ILY
Device Description
The Cynosure 1064nm Diode Laser is the laser device that delivers laser energy in the 1064nm wavelength. The Cynosure 1064nm Diode Laser is a non-invasive device that emits light energy to for the purpose of causing the therapeutic elevation of tissue temperature.
The Cynosure Diode laser is a compact diode laser system. The Cynosure Diode laser's overall size, cooling needs, and electrical service requirements are substantially reduced compared to other lasers with similar power capabilities.
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
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)
Performance (bench) testing summaries are included in this submission. In testing at 63W and 73W device increased and maintained the tissue temperature at 40 - 45°C
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
§ 890.5500 Infrared lamp.
(a)
Identification. An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.(b)
Classification. Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.
0
1.0 510(k) Summary
510(K) Owner:
CYNOSURE, INC. 5 Carlisle Road Westford, MA 01886
Contact:
Irina Kulinets VP of Regulatory Affairs and Quality Systems Cynosure, Inc. Telephone: 978-367-2350
Manufacturer:
CYNOSURE, INC. 5 Carlisle Road Westford, MA 01886 Telephone: 978-256-4200
Date Prepared:
December 21, 2012
Trade name:
Cynosure 1064nm Diode Laser
ILY (lamp, infrared, therapeutic heating)
Common name:
Infrared Lamp
Classification name:
21 CFR 890.5500
Product Code(s):
Classification:
Class II
Review Panel: · General & Plastic Surgery
Predicate Devices (Claiming Substantial Equivalence):
Biolase Technology, Inc. ezlase™M K083595
2 2013 MAY
1
CYNOSURE, INC. HILT Family Laser K051537
CYNOSURE, INC. SmoothShapes XV® System · K100230
Summary Description of the Device:
The Cynosure 1064nm Diode Laser is the laser device that delivers laser energy in the 1064nm wavelength. The Cynosure 1064nm Diode Laser is a non-invasive device that emits light energy to for the purpose of causing the therapeutic elevation of tissue temperature.
The Cynosure Diode laser is a compact diode laser system. The Cynosure Diode laser's overall size, cooling needs, and electrical service requirements are substantially reduced compared to other lasers with similar power capabilities.
Intended Use / Indications for Use:
The Cynosure 1064nm Diode Laser Device is intended to provide heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and/or the temporary relaxation of muscle.
Technological Characteristics:
The Cynosure 1064nm Diode Laser has equivalent technological characteristics and fundamental scientific technology as the FDA cleared ezlase™ (Biolase Technology, Inc.), the Cynosure HILT Family Laser (El En) and the Cynosure SmoothShapes XV® System. K083595. K051537 and K100230. respectively.
Performance Standards:
This device conforms to the Laser Performance Standard (21 CFR 1040). No additional performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices.
Performance Data:
2
Performance (bench) testing summaries are included in this submission. In testing at 63W and 73W device increased and maintained the tissue temperature at 40 - 45°C
Substantial Equivalence:
There are no differences in technological characteristics or performance specifications between the ezlase™ (Biolase Technology, Inc.) and the Cynosure HILT Family Laser (El En) K083595, K051537 respectively and Cynosure's proposed device that would affect safety and efficacy. Both predicates utilize the same fundamental technology and the same indications for use as the proposed device. The Cynosure 1064nm Diode Laser has the equivalent delivered maximum fluence cleared previously by the FDA under 510(k) K100230 (SmoothShapes XV® System). The Cynosure 1064nm Diode Laser is as safe and effective as the predicate devices which have equivalent intended use/indications for use, principle of operation, technological characteristics and similar performance specifications. The Cynosure 1064 Diode Laser is substantially equivalent to the predicate devices and does not raise any additional questions of safety and effectiveness.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its wings or body. The bird is positioned to the right of a circular text element. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" and is arranged around the circumference of the circle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
May 2, 2013
Cynosure, Inc. % Ms. Irina Kulinets VP of Regulatory Affairs and Quality Systems 5 Carlisle Road Westford, Massachusetts 01886
Re: K123971
Trade/Device Name: Cynosure 1064nm Diode Laser Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: Class II Product Code: ILY Dated: April 16, 2013 Received: April 17, 2013
Dear Ms. Kulinets:
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. Iisting 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
4
Page 2 - Ms. Irina Kulinets
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/ResourcesforYou/Industry/default.htm.
FOR
Sincerely yours,
Peter Di Rumm -S
Mark N. Melkerson Acting Director Division of Surgical Devices, Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K123971
Device Name: Cynosure 1064nm Diode Laser
Indications For Use: The Cynosure 1064nm Diode Laser Device is intended to provide heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and/or the temporary relaxation of muscle.
Over-The-Counter U Prescription Use X AND/OR (Part 21 CFR 801 Subpart D) 1 CFR 801 Subpa
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil R Ogden 2013.05.02 12:18:41 -04'00'
(Division Sign-Off) For MXM
Division of Surgical Devices
510(k) Number K123971
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