(84 days)
The MedX LCS Laser Series is indicated for adjunctive use in the temporary relief of hand and wrist pain associated with carpal tunnel syndrome.
MedX LCS Laser Series primarily consists of a hand held portable laser device and the battery recharger. The hand held laser contains the laser diodes and assembly, circuit board, electronics, battery and labels. The power receptacle for the battery recharger is located at the base of the hand held laser.
I'm sorry, but the provided text does not contain the detailed information necessary to complete the requested table and study breakdown. The document is primarily a 510(k) summary for the MedX LCS Laser Series, focusing on its classification, predicate device, and FDA's substantial equivalence determination.
It does not include:
- Acceptance criteria for device performance.
- Any study details, such as sample sizes, data provenance, expert qualifications, ground truth establishment, adjudication methods, or results of a comparative effectiveness study.
- Standalone algorithm performance.
Therefore, I cannot fulfill the request as the required information is not present in the provided text.
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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS DATA
| Model No./Name: | MedX LCS Laser Series |
|---|---|
| Classification: | Lamp Non-heating - Section B - NHNPhysical Medicine Device, 21 CFR 89.5500 (Class II) |
| Predicate Device: | MicroLight 830T Laser - K010175 |
This summary of the 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
Description of the Device
MedX LCS Laser Series primarily consists of a hand held portable laser device and the battery recharger. The hand held laser contains the laser diodes and assembly, circuit board, electronics, battery and labels. The power receptacle for the battery recharger is located at the base of the hand held laser.
The MedX LCS is an 830 nm infrared laser indicated for adjunctive use in the temporary management of hand and wrist pain associated with carpal tunnel syndrome. The product has been deemed substantially equivalent to the MicroLight 830T Laser - K010175.
The device meets the requirements of UL standards in United States.
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three lines forming its body and head. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
SEP 1 0 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MedX Electronics Inc. Anita Saltmarche Vice-President of Clinical and Scientific Affairs 3535 Laird Road, Unit 2 Mississauga, Ontario Canada L5L 5Y7
Re: K021985
Trade/Device Name: MedX LCS 090 Laser Series Regulation Number: 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: NHN Dated: June 15, 2002 Received: June 18, 2002
Dear Ms. Saltmarche:
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, listing of devices, good manufacturing 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 may be subject to such 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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801); good manufacturing practice requirements as setforth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 – Ms. Anita Saltmarche
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Celia M. Witten, Ph.D., M.D.
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: K021985
Device Name: LCS 090 Laser Series
INDICATIONS FOR USE:
The MedX LCS Laser Series is indicated for adjunctive use in the temporary relief of hand and wrist pain associated with carpal tunnel syndrome.
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109
OR
Over-the-Counter Use (Optional Format 1-2-96)
Hupf Plivelr
(Division Sign-off) Division of General Restorative Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________ KOZI985
§ 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.