(129 days)
Not Found
No
The summary describes a low-level infrared lamp for heat therapy and does not mention any AI or ML components or functionalities.
Yes
The device is intended to provide topical heating 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 promoting relaxation of muscles, all of which are therapeutic purposes.
No
The device is intended to provide topical heating for pain relief, increased blood circulation, and muscle relaxation, which are therapeutic rather than diagnostic purposes.
No
The device description explicitly states it is a portable, AC and battery operated non-invasive, low level infrared lamp with a drive unit/power supply and optional treatment probes containing radiating elements, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for providing topical heating to the body for therapeutic purposes (pain relief, increased circulation, muscle relaxation). This is a direct interaction with the patient's body.
- Device Description: The description confirms it's a non-invasive, low-level infrared lamp that provides heat therapy. This is a physical therapy device.
- Lack of IVD Characteristics: There is no mention of analyzing samples from the human body (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Laser Sys*Stim 540, Model ME 540 is intended to emit energy in the infrared spectrum to provide topical 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 promoting relaxation of muscles.
Product codes
ILY
Device Description
The Laser Sys*Stim 540, Model ME 540, is a portable, AC and battery operated non-invasive, low level infrared lamp that provides continuous and pulsed heat therapy at a fixed frequency. The system consists of a drive unit/power supply that houses the electronics, controls and displays and optional treatment probes that contain the visible and infrared radiating elements.
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
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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
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Summary of Performance Studies
Production and quality control performance and safety testing shall be performed on each system pursuant to compliance with all applicable safety standards and regulations for low level laser therapy systems.
Key Metrics
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Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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MAY - 6 2005
LASER SYS*STIM® 540 MODEL ME 540 510(K) SUMMARY STATEMENT [K(TBD)]
043586
Mettler Electronics Corp. Submitter's Name: 1333 South Claudina Street Address: Anaheim, CA 92805 800-854-9305 or 714-533-2221 x314 Telephone: 714-781-8984 Fax: Rob Fleming, Regulatory Compliance Manager Contact: and Official Correspondent robfleming@mettlerelectronics.com Email:
December 22, 2004 Date Prepared:
Device Name:
- a. TRADE NAME:
- b. CLASSIFICATION NAME:
- c. COMMON NAME:
Laser Sys*Stim 540, Model ME 540 Infrared Lamp Low Level Laser Therapy (LLLT)
Predicate Devices:
In our opinion, the Laser Sys*Stim® 540, Model ME 540, is substantially equivalent to other infrared therapeutic lamps that are currently in commercial distribution. These predicate devices include the MedX 1100 Console (K032231), Dynatronics' Solaris D890 Therapy Probe (K040729) and Dynatronics' Solaris D880 Infrared Probe (K031329).
Description of Device:
The Laser Sys*Stim 540, Model ME 540, is a portable, AC and battery operated non-invasive, low level infrared lamp that provides continuous and pulsed heat therapy at a fixed frequency. The system consists of a drive unit/power supply that houses the electronics, controls and displays and optional treatment probes that contain the visible and infrared radiating elements.
1
LASER SYS*STIM® 540 MODEL ME 540 510(K) SUMMARY STATEMENT [K(TBD)]
Device Intended Use Statement:
510(k) Number: TBD
Device Name: Laser Sys*Stim, Model ME 540
Indication for use: The Laser Sys*Stim, Model ME 540, is intended to emit energy in the infrared spectrum to provide topical 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 promoting relaxation of muscles.
Comparison of Technological Characteristics Between ME 540 and Predicate Devices:
The Laser Sys*Stim, Model ME 540, and predicate devices listed above, are infrared lamps as defined in 21 CFR 890.5500 using infrared and visible laser diodes that generate topical heating for the purpose of elevating tissue temperatures for temporary relief of muscle and joint pain.
Testing:
Production and quality control performance and safety testing shall be performed on each system pursuant to compliance with all applicable safety standards and regulations for low level laser therapy systems.
Conclusion:
The Laser Sys*Stim, Model ME 540, is substantially equivalent to, and shares the same indications for use, general technical characteristics and user interface controls as, the listed predicate devices. It is designed to provide topical heating in the infrared and visible wavelength spectrum at energy levels previously found acceptable by the Food and Drug Administration. Each unit shall undergo compliance verification testing prior to introduction into interstate commerce to insure conformance to specifications and applicable safety standards.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo features the department's name encircling a symbol. The symbol consists of four stylized, abstract shapes that resemble human figures or birds in flight. The logo is presented in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 6 2005
Mr. Robert E. Fleming Regulatory Compliance Manager Mettler Electronics Corporation 1333 South Claudina Street Anaheim, California 92805
Re: K043586
Trade/Device Name: Laser Sys*Stim 540, Model ME 540 Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: ILY Dated: March 9, 2005 Received: March 10, 2005
Dear Mr. Fleming:
We have reviewed your Section 510(k) premarket notification of intent to market the device w Chave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreated of the enactment date of the Medical Device Amendments, or to Connieres that have been reclassified in accordance with the provisions of the Federal Food, Drug, de vices that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The 1 ou may, mercrore, market the Act include requirements for annual registration, listing of general controls providering practice, 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 your device to such additional controls. Existing major regulations affecting your device it may be subject to saon additions, Title 21, Parts 800 to 898. In addition, FDA can be found in the Oous of concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease be advised that i Drivice complies with other requirements of the Act that I DA has made a actering administered by other Federal agencies. You must of ally I cuclar statutes and regalances ancluding, but not limited to: registration and listing (21 Comply with an the Act 3 requirements, 01); good manufacturing practice requirements as set CFR art 6077, laboring (21 OS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality bystems (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 -- Mr. Robert E. Fleming
This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter will anow you to oegin maine of substantial equivalence of your device to a legally premarket notification: "The PDF 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 do november 10 . Also, please note the regulation entitled, Condor the Office of Course to premarket notification" (21CFR Part 807.97). You may obtain Misolanding of Icrerchee to premainsvilibilities under the Act from the Division of Small other general Information on your response Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: Laser Sys*Stim 540, Model ME 540
Indications for Use:
The Laser Sys*Stim 540, Model ME 540 is intended to emit energy in the infrared spectrum to provide topical 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 promoting relaxation of muscles.
Prescription Use X (Per 21 CFR 801 Subpart D) AND/OR
Over the Counter Use (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)
Signature
tive
043586