(61 days)
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.
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.
I am sorry, but I cannot provide the requested information because the provided text does not contain any acceptance criteria or a study demonstrating device performance against such criteria.
The document is a 510(k) summary for a medical device (MLS Family Diode Laser) and the associated FDA clearance letter. These documents primarily focus on demonstrating substantial equivalence to a legally marketed predicate device, rather than presenting de novo performance criteria or results from a clinical study to prove such criteria are met.
Here's why the information cannot be extracted based on the input provided:
- No Acceptance Criteria: The 510(k) summary lists "Nonclinical Performance Data: none" and "Clinical Performance Data: none." This explicitly states that no performance data was submitted or reviewed. Therefore, there are no acceptance criteria outlined for such performance.
- No Study Details: Without any performance data, there is no study described to analyze. All the sub-points you requested (sample size, data provenance, ground truth, MRMC study, standalone performance, training set details) are contingent on a study being performed and reported, which is not the case here.
- Focus on Substantial Equivalence: The primary objective of this 510(k) submission was to establish "substantial equivalence" to a predicate device, as explicitly stated in the "Comparison" section. This process often relies on demonstrating similar design, materials, and intended use as a device already on the market, rather than conducting new clinical trials with specific performance targets.
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051922
SEP 1 4 2005
510(K) Summary
| 510(K) Summary | |
|---|---|
| Submitter: | Cynosure Inc5 Carlisle RoadWestford, MA 01886 |
| Contact: | George ChoSenior 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 Lamp21 CFR 890.5500 |
| Equivalent Device: | MLT-1000 IR Laser System |
| Device Description: | The 'MLS Family' Diode Laser provides 808 and 905 nmwavelengths. Laser emission activation is by user selectablecontroller. Electrical requirement is 230 VAC, 20A, 50-60 Hz, singlephase. |
| Intended Use: | The 'MLS Family' Diode Laser is intended to provide topical heatingfor the purpose of elevating tissue temperature for temporary relief ofmuscle and joint pain and stiffness, arthritis pain, or muscle spasm, thetemporary increase in local blood circulation and/or promotingrelaxation of muscle. |
| Comparison: | The 'MLS Family' Diode Laser has the same indications for use, thesame principle of operation, and similar performance specifications asthe predicate devices. |
| Nonclinical Performance Data: | none |
| Clinical Performance Data: | none |
| Conclusion: | The 'MLS Family' Diode Laser is a safe and effective device for theindications 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 (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
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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)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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510(k) Number K051922
§ 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.