ASA 'M FAMILY' DIODE LASER, MODEL MI, MIX5, M6

K051922 · Cynosure, Inc. · ILY · Sep 14, 2005 · Physical Medicine

Device Facts

• Record ID: K051922
• Device Name: ASA 'M FAMILY' DIODE LASER, MODEL MI, MIX5, M6
• Applicant: Cynosure, Inc.
• Product Code: ILY · Physical Medicine
• Decision Date: Sep 14, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The 'MLS Family' Diode Laser is intended to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of muscle and joint pain and stiffness, arthritis pain, or muscle spasm, the temporary increase in local blood circulation and/or promoting relaxation of muscle.

Device Story

The 'MLS Family' Diode Laser (models Mix5, M1, M6) is a therapeutic infrared lamp system. It emits laser energy at 808 nm and 905 nm wavelengths to provide topical heating. The device is operated by a user via a selectable controller. It is intended for clinical use to elevate tissue temperature, thereby relieving pain and stiffness associated with muscles, joints, and arthritis, while also promoting local blood circulation and muscle relaxation. The device operates on 230 VAC power.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Diode laser system emitting 808 nm and 905 nm wavelengths. Powered by 230 VAC, 20A, 50-60 Hz, single phase. User-selectable controller for laser emission activation. Classified as an infrared lamp under 21 CFR 890.5500.

Indications for Use

Indicated for patients requiring topical heating for temporary relief of muscle and joint pain, stiffness, arthritis pain, muscle spasms, increased local blood circulation, or 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

• MLT-1000 IR Laser System

Submission Summary (Full Text)

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051922
SEP 1 4 2005
**510(K) Summary**

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| 510(K) Summary | |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Cynosure Inc<br>5 Carlisle Road<br>Westford, MA 01886 |
| Contact: | George Cho<br>Senior Vice President |
| Date Summary Prepared: | July 14, 2005 |
| Device Trade Name: | 'MLS Family' Diode Laser - MLS Mix5, MLS M1, MLS M6 |
| Common Name: | Diode Laser |
| Classification Name: | Infrared Lamp<br>21 CFR 890.5500 |
| Equivalent Device: | MLT-1000 IR Laser System |
| Device Description: | The 'MLS Family' Diode Laser provides 808 and 905 nm<br>wavelengths. Laser emission activation is by user selectable<br>controller. Electrical requirement is 230 VAC, 20A, 50-60 Hz, single<br>phase. |
| Intended Use: | The 'MLS Family' Diode Laser is intended to provide topical heating<br>for the purpose of elevating tissue temperature for temporary relief of<br>muscle and joint pain and stiffness, arthritis pain, or muscle spasm, the<br>temporary increase in local blood circulation and/or promoting<br>relaxation of muscle. |
| Comparison: | The 'MLS Family' Diode Laser has the same indications for use, the<br>same principle of operation, and similar performance specifications as<br>the predicate devices. |
| Nonclinical Performance Data: | none |
| Clinical Performance Data: | none |
| Conclusion: | The 'MLS Family' Diode Laser is a safe and effective device for the<br>indications specified. |
| Additional Information: | none |

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a bird-like figure with three wing-like shapes.

Public Health Service

SEP 1 4 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. George Cho Senior Vice President Medical Technology Cynosure, Inc. 5 Carlisle Road Westford, Massachusetts 01886

Re: K051922

K031322
Trade/Device Name: MLS Family Diode Laser-MLS Mix5, MLS M1, MLS M6 Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: ILY Dated: August 25, 2005 Received: August 26, 2005

Dear Mr. Cho:

We have reviewed your Section 510(k) premarket notification of intent to market the device t we nave reviewed your Section 310(t) presentially equivalent (for the indications ferenced above and have actering ally marketed predicate devices marketed in interstate for use stated in the enclosure) to regally manities of the Medical Device Amendments, or to commerce provide to May 20, 1770, the enaounce with the provisions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA). alla Cosmelle Act (Tec) that to her requent of the general controls provisions of the Act. The You may, therefore, manset the act include requirements for annual registration, listing of general controls provisions of the tice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it II your device is crassified (800 a0010) ins existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations FDA may be subject to sueil additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Out of Pourses concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I Dr. 5 issuance errour device complies with other requirements of the Act that I DA has made a determinations administered by other Federal agencies. You must of any reactal statutes and regarations and adding, but not limited to: registration and listing (21 comply with an the Not 3 requirements, and manufacturing practice requirements as set CTN in the quality systems (DF CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2- Mr. George Cho

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin maxemily of substantial equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivalize and thus premarket nothealton. The PDA midning of backantal vque
marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your de vice of 1.5. Also, please note the regulation entitled, the lists of contact the Office of Complance at (210) 276-676 (21CFR Part 807.97). You may obtain "Misbranding by reference to premance notification of the Act from the Division of Small other general information on your responsionies and with the number [phone] or
Manufacturers, International and Consumer Assistance at its toll-demomain btml Manufacturers, International and Collisanter Press. Internet in the main.html

Sincerely yours,

Barbara BuehrD

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): _K051922_

Device Name: _ 'MLS Family' Diode Laser -- MLS Mix5, MLS M1, MLS M6

Indications For Use:

. . . . . .

The 'MLS Family' Diode Laser is intended to provide topical heating for the purpose of elevating tissue The MLS Family 'Diode Laser is filehauto provide sopical not stiffitis pathritis pain, or muscle
temperature for the temporary relief of muscle and joint pain and stimation o temperature tor the temporary reflet of muscle and John pain and or services relaxation of muscle.

> OR Prescriptive Use_ X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (Part 21 CFR 801 Subpart C)

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**510(k) Number** K051922