(206 days)
The MicroLight ML830 d contains infrared lamps that are indicated for use 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, arthritis and muscle spasm; relieving stiffness; promoting relaxtion of pain, artifitis and inuscle spassily increase local blood circulation where applied.
The ML830®d is an innovative, safe, easy to use, hand-held, non-invasive device The ML830 u is an innovative, sare, easy es approximately % pound and has a designed for in-nonic use. "The device worgine upper of these (34 square centimeters).
The ML830®d contains 12 light emitting diodes and 12 infrared diodes with The NILGSV a commits TF ingile change
wavelengths of 660 nanometers, and 880 nanometers, respectively, with total or waverongais of approximately 500 milliwatts.
The provided text is a 510(k) Premarket Notification Summary for the ML830®d infrared lamp. This document outlines the device's technical characteristics and intended use but does not contain any information about a study with acceptance criteria or reported device performance.
The core of this document is to demonstrate that the ML830®d is substantially equivalent to a predicate device, the Dio LFT 3000 (cleared under K022888). Substantial equivalence means that a new device is as safe and effective as a legally marketed predicate device. This typically relies on comparing design, materials, chemical composition, energy source, and intended use, rather than conducting new clinical trials for safety and effectiveness.
Therefore, I cannot provide the requested information because the document does not describe a study that proves the device meets acceptance criteria. The clearance is based on its identity to a previously cleared device.
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041364 1/2
510(k) PREMARKET NOTIFICATION SUMMARY (per 21 CFR 807.92)
ML830®d - PRELIMINARY STATEMENT
The ML830®d
Applicant seeks market clearance for a device that is already cleared by another applicant, Light Force Therapy, Inc. under K022888. However, Applicant seeks the right to market that same device without making reference to the original applicant or its labeling.
I. Applicant:
DEC 1 3 2004
MicroLight Corporation of America 2935 Highland Lakes Drive Missouri City, Texas 77459
| Contact Person: | Fred A. Simpson, Esq.c/o Jackson Walker L.L.P.713-752-4248 telephone713-752-4221 facsimilee-mail fsimpson@jw.com |
|---|---|
| ----------------- | ---------------------------------------------------------------------------------------------------------------------------------- |
September 22, 2004 Date Prepared:
II. Device Name
| Proprietary Name: | ML830®d |
|---|---|
| Common / Usual Name: | Infrared Lamp |
| Classification Name: | Infrared Lamp (21 CFR 890.550) |
| Product Code: | NHN |
III. Predicate Device
The ML830 d is substantially equivalent to the Dio LFT 3000 cleared by the Agency under K022888. The manufacturer of the Dio LFT 3000 has agreed to supply MicroLight Corporation of America with the Dio LFT 3000 units which MicroLight will specifically label with the designation “ML830®d” and publish and distribute with independent sales literature and instructions for use.
IV. Intended Use of the Device
The MicroLight ML830 d contains infrared lamps that are indicated for use 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
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pain, arthritis and muscle spasm; relieving stiffness; promoting relaxtion of pain, artifitis and inuscle spassily increase local blood circulation where applied.
Description of the Device V.
The ML830®d is an innovative, safe, easy to use, hand-held, non-invasive device The ML830 u is an innovative, sare, easy es approximately % pound and has a designed for in-nonic use. "The device worgine upper of these (34 square centimeters).
The ML830®d contains 12 light emitting diodes and 12 infrared diodes with The NILGSV a commits TF ingile change
wavelengths of 660 nanometers, and 880 nanometers, respectively, with total or waverongais of approximately 500 milliwatts.
Summary of the technical characteristics of the ML830®d to the referenced VI. predicate devices.
The ML830®d is identical to the Dio LFT 3000 marketed by Light Force Therapy, Inc. Therefore, the ML830®d has identical technological characteristics Therapy, Inc. Therefore, the ML830®d has features... ...regarding safety as the predicate device. The only difference is that the ML830®d will be marketed under MicroLight's brand name.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird-like figure.
DEC 1 3 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MicroLight Corporation of America c/o Mr. Fred A. Simpson, Esq. Jackson Walker L.L.P. 1401 McKinney Street, Suite 1900 Houston, Texas 77010
Re: K041364
Trade/Device Name: ML830®d Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: ILY Dated: September 22, 2004 Received: September 23, 2004
Dear Mr. Simpson:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications ferenced about and in sure) to legally marketed predicate devices marketed in interstate for use stated in the encreations) (3 tegain) and entirent date of the Medical Device Amendments, or to conmision to Frid 11125 20, 2017, 11:11
devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, de nees that have been require approval of a premarket approval application (PMA). and Costhele Fee (. 10) may the device, subject to the general controls provisions of the Act. The r ou may, cherefore, mains of the Act include requirements for annual registration, listing of genoral ocharitis proficturing 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 If your device is exastinon (tional controls. Existing major regulations affecting your device can may or babyes to and was a made as a legulations, 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 r lease of action that i Dry over device complies with other requirements of the Act that I Dr has Interves and regulations administered by other Federal agencies. You must of any I cacial stututes and regaranents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Orth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forul in and quinn control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Fred A. Simpson, Esq.
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and w yourse organ finding of substantial equivalence of your device to a legally premailed predicated on "The 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 advisional (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other genoral 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,
Miriam C. Provost
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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APPENDIX B
STATEMENT OF INDICATIONS FOR USE
K041364 510(k) Number:
ML830®d Device Name:
- Indications for Use: MicroLight Corporation of America's “ML830®d” is an infrared lamp that is indicated for use 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, arthritis and muscle spasm; relieving stiffness; promoting relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
YES OR Prescription Use: (Per 21 CFR 801.109)
Over the Counter Use: (Optional Format 1-2-96)
Muriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
(Division Sign-Off)
510(k) Number K041364
510(k) Number K041364
ML830 d 510(k) Premarket Notification, September 22, 2004
§ 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.