(111 days)
Not Found
No
The description focuses on the physical components (LEDs) and the mechanism of action (infrared heat for topical heating). There is no mention of AI, ML, data processing, or algorithms that would suggest the use of such technology.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is intended for "temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm," directly indicating a therapeutic purpose.
No
The document describes the device as providing topical heating for temporary relief of pain, stiffness, and spasms, indicating a therapeutic rather than diagnostic purpose.
No
The device description clearly states it consists of physical components like infrared and red diodes (LEDs) packaged in a plastic head, indicating it is a hardware device that emits light.
Based on the provided information, the Quasar MD21 infrared heat lamp is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for providing topical heating to elevate tissue temperature for therapeutic purposes (pain relief, increased circulation, muscle relaxation). This is a direct application to the body, not an in vitro test.
- Device Description: The description details a device that emits infrared and red light for heating. There is no mention of analyzing biological samples (blood, urine, tissue, etc.) which is the core function of an IVD.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Detecting or measuring substances in biological samples.
- Providing information for diagnosis, monitoring, or screening of diseases or conditions based on sample analysis.
The Quasar MD21 is a therapeutic device that applies energy to the body for physical effects, not a diagnostic device that analyzes samples outside the body.
N/A
Intended Use / Indications for Use
The Quasar MD21 infrared heat lamp is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature. This device may be used to provide temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm. This device may temporarily increase local blood circulation, and may be used to promote relaxation of the muscle tissue.
Product codes (comma separated list FDA assigned to the subject device)
ILY
Device Description
The Quasar MD21 consists of a collection of both infrared and red diodes [LEDs], packaged in a compact plastic head. The system emits pulsed light in the infrared spectrum to provide topical heating. The red diodes [LEDs], provide a visible indication that the unit is in operation. For operation turn on LEDs for a time period of twenty-five (25) minutes prior to use.
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
Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing of the Quasar MD21 included functional performance testing and electrical safety testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
K032379 (pg 1 of 2)
510(k) Submission, Infrared Lamp, 21 CFR 890.5500 Quantum Skincare, Inc., Ringgold, LA 71068
Summary
This summary of 510(k)-safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR Part 807.92 for the Quasar MD21 Infrared Heat Lamp.
Company making the submission:
| Name: | This summary is submitted in behalf of:
Quantum Skincare, Inc. | or | This summary is submitted by: |
|--------------------|--------------------------------------------------------------------------|----|----------------------------------------------------------------------------------|
| Address: | 3157 Military Road
Ringgold, LA 71068 . | | Delphi Consulting Group
11874 South Evelyn Circle
Houston, Texas 770713404 |
| Telephone:
Fax: | 1-318-894-9490 | | 1-713-723-4080
1-775-429-9524 |
| Contact: | Jim Cobb
President | | J. Harvey Knauss
Consultant |
| E-mail: | Jim@quantumskincare.com | | harvey@delphiconsulting.com |
1. Device Name:
・
| Trade/Proprietary Name: | Quasar MD21 Infrared Heat Lamp. |
|---|---|
| Common/Usual Name: | Infrared heat lamp. |
| Classification Name: | Infrared lamp 21 CFR § 890.5500 |
2. Predicate Device:
The Quasar MD21 Infrared Heat Lamp is substantially equivalent to other infrared lamps on the market, such as the Mu Photonics Pain Therapist, K012598 manufactured by Nu Photonics, Inc., and Biolight PCD,
3. Intended use of the Device:
The Quasar MD21 infrared heat lamp is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature. This device may be used to provide temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm. This device may temporarily increase local blood circulation, and may be used to promote relaxation of the muscle tissue.
1
4. Description of the Device:
The Quasar MD21 consists of a collection of both infrared and red diodes [LEDs], packaged in a compact plastic head. The system emits pulsed light in the infrared spectrum to provide topical heating. The red diodes [LEDs], provide a visible indication that the unit is in operation. For operation turn on LEDs for a time period of twenty-five (25) minutes prior to use.
5. Summary of the technological characteristics of the device Compared to predicate devices:
The Quasar MD21 and the above referenced predicate devices are infrared lamps as defined in 21 CFR § 890.5500. These devices utilize infrared diodes [LEDs], to provide topical heating for the temporary relied of muscle and/or joint pain. The temperatures achieved by these devices are the same, using a similar number of diodes {LEDs], over a similar coverage area. The devices are handheld, and intended to be placed directly on the skin or held just over the skin to provide the heating.
6. Testing:
Testing of the Quasar MD21 included functional performance testing and electrical safety testing.
7. Conclusions:
Based upon the testing and comparison to the predicate devices, the Quasar MD21 has the same intended uses, with similar technological characteristics. The system performs as intended and raises no new safety or effectiveness issues.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other, representing the department's focus on people and health.
Public Health Service
NOV 2 0 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ouantum Skincare, Inc. c/o Mr. J. Harvey Knauss Delphi Consulting Group 11874 South Evelyn Circle Houston, Texas 77071-3404
Re: K032379
Trade/Device Name: Quasar MD21, Infrared Lamp Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: ILY Dated: October 9, 2003 Received: October 14, 2003
Dear Mr. Knauss:
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 set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
3
Page 2 - Mr. J. Harvey Knauss
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), please contact the Office of Compliance at (301) 594-4659. 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 Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 on (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
4
510(k) Number KO32379
Quasar MD21, Infrared Lamp Device Name:
Indications for use:
The Quasar MD21 infrared heat lamp is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature. This device may be used to provide temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm. This device may temporarily increase local blood circulation, and may be used to promote relaxation of the muscle tissue.
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X
OR
Over-The-Counter Use
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
Muriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K032379