← Product Code [ILY](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ILY) · K051922 # ASA 'M FAMILY' DIODE LASER, MODEL MI, MIX5, M6 (K051922) _Cynosure, Inc. · ILY · Sep 14, 2005 · Physical Medicine · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ILY/K051922 ## Device Facts - **Applicant:** Cynosure, Inc. - **Product Code:** [ILY](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ILY.md) - **Decision Date:** Sep 14, 2005 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 890.5500 - **Device Class:** Class 2 - **Review Panel:** Physical Medicine - **Attributes:** Therapeutic ## Indications for 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. ## Regulatory 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) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ 051922 SEP 1 4 2005 **510(K) Summary** ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | 510(K) Summary | | |-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter: | Cynosure Inc
5 Carlisle Road
Westford, MA 01886 | | Contact: | George Cho
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
21 CFR 890.5500 | | Equivalent Device: | MLT-1000 IR Laser System | | Device Description: | The 'MLS Family' Diode Laser provides 808 and 905 nm
wavelengths. Laser emission activation is by user selectable
controller. Electrical requirement is 230 VAC, 20A, 50-60 Hz, single
phase. | | Intended Use: | The 'MLS Family' Diode Laser is intended to provide topical heating
for the purpose of elevating tissue temperature for 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. | | Comparison: | The 'MLS Family' Diode Laser has the same indications for use, the
same principle of operation, and similar performance specifications as
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
indications specified. | | Additional Information: | none | {1}------------------------------------------------ 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. {2}------------------------------------------------ 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 (800) 638-2041 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 {3}------------------------------------------------ 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) (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Cheulare Buelund for MXM **Division Sigr** Division of ( D6RND ALLA DEVELLA and **510(k) Number** K051922 --- **Source:** [https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ILY/K051922](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ILY/K051922) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com