CYNOSURE 1064NM DIODE LASER

K123971 · Cynosure, Inc. · ILY · May 2, 2013 · Physical Medicine

Device Facts

• Record ID: K123971
• Device Name: CYNOSURE 1064NM DIODE LASER
• Applicant: Cynosure, Inc.
• Product Code: ILY · Physical Medicine
• Decision Date: May 2, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Cynosure 1064nm Diode Laser is a compact, non-invasive therapeutic heating device. It emits 1064nm wavelength laser energy to elevate tissue temperature. Used by clinicians to provide temporary relief of minor muscle and joint pain, stiffness, arthritis pain, muscle spasms, and to increase local blood circulation and relax muscles. Device operation involves delivering laser energy to target tissue; performance testing confirms ability to maintain tissue temperature between 40-45°C at 63W and 73W. Benefits include non-invasive pain management and muscle relaxation.

Clinical Evidence

Bench testing only. Testing at 63W and 73W demonstrated the device's ability to increase and maintain tissue temperature at 40-45°C.

Technological Characteristics

1064nm diode laser system; compact form factor; conforms to 21 CFR 1040 Laser Performance Standard. Energy source: diode laser. No specific materials or software architecture details provided.

Indications for Use

Indicated for patients requiring therapeutic heating for temporary relief of minor muscle/joint pain, stiffness, minor arthritis pain, muscle spasm, temporary increase in local blood circulation, and temporary muscle relaxation.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Biolase Technology, Inc. ezlase™ (K083595)
• CYNOSURE, INC. HILT Family Laser (K051537)
• CYNOSURE, INC. SmoothShapes XV® System (K100230)

Submission Summary (Full Text)

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K123971|

# 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: [phone]

Manufacturer:

CYNOSURE, INC. 5 Carlisle Road Westford, MA 01886 Telephone: [phone]

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

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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:

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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.

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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

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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 [phone] or [phone] 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

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# 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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