(34 days)
Not Found
No
The description focuses on the hardware (LEDs, light unit, positioning arm) and a simple firmware timer. There is no mention of AI, ML, image processing, or any data-driven decision-making process.
Yes
The device is intended for therapeutic uses such as relaxation of muscles, pain relief, and increased local blood circulation.
No
The device is intended for therapeutic purposes such as muscle relaxation, pain relief, and increasing blood circulation, not for diagnosing medical conditions.
No
The device description explicitly states it is a "compact light source" with "light sources are narrow bandwidth LEDs mounted in an array," indicating it is a hardware device that emits light. It also mentions a "firmware timer," which is software, but the core function and components are hardware-based.
Based on the provided information, the Dermillume Red HR1000 infrared lamp is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device that applies light to the skin surface for therapeutic purposes (muscle relaxation, pain relief, increased blood circulation). This is a direct interaction with the body, not a test performed on samples taken from the body.
- Device Description: The description details a light source and its components, designed to deliver light to the skin. This aligns with a physical therapy or therapeutic device, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Dermillume Red HR1000 does not fit this description.
N/A
Intended Use / Indications for Use
The Dermillume Red HR1000 infrared lamp is intended for the relaxation of muscles and relief of muscle spasms, temporary relief of minor muscle and joint aches, pains and stiffness, temporary relief of minor pain and stiffness associated with arthritis, and to temporarily increase local blood circulation.
Product codes (comma separated list FDA assigned to the subject device)
ILY
Device Description
The Dermillume Red HR1000 lamp is a compact light source that delivers high intensity narrow band red and near infrared light to the skin surface. The light sources are narrow bandwidth LEDs mounted in an array to give even and safe illumination of skin surfaces. The principal parts of the lamp are a light unit, positioning arm and firmware timer to control duration of exposure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin surface
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)
The performance data obtained from bench testing of the Dermillume lamp substantiates that the irradiance at a practicable distance from the skin surface is comparable with the cited predicated lamps. The mode of operation, technology and general principles of this lamp are the same as the predicate lamps. There are no significant adverse reactions observed in clinical studies using this technology. The lamp is safe and efficacious.
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.
K011355, K042813, K931261, K042532, K043575
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
510(k) Summary 2.
510(k) Summary
| Applicant & Submitter: | Care Electronics, Inc. |
|---|---|
| Address: | 4700 Sterling Dr., Suite D |
| Boulder, CO 80301 | |
| Phone: | 303-444-2273 |
| Fax: | 303-447-3502 |
| Contact Person: | Thomas Moody |
| Preparation Date: | 6/21/05 |
| Lamp Submitted: | Dermillume Red Lamp |
| Proprietary Name: | Dermillume Red |
| Common Name: | Infrared Therapy Lamp |
| Classification: | Lamp, Infrared; Class II Product code: ILY |
| Predicate Lamps: | Biolight PCD (K011355), Biobeam (K042813), Anodyne |
| Therapy Systems (K931261), PremIR 818 (K042532), | |
| Dermillume Pro1000 (K043575) | |
| Lamp Description: | The Dermillume Red HR1000 lamp is a compact light source |
| that delivers high intensity narrow band red and near infrared | |
| light to the skin surface. The light sources are narrow | |
| bandwidth LEDs mounted in an array to give even and safe | |
| illumination of skin surfaces. | |
| The principal parts of the lamp are a light unit, positioning arm | |
| and firmware timer to control duration of exposure. | |
| Intended Use: | The Dermillume Red HR1000 infrared lamp is intended for the |
| relaxation of muscles and relief of muscle spasms, temporary | |
| relief of minor muscle and joint aches, pains and stiffness, | |
| temporary relief of minor pain and stiffness associated with | |
| arthritis, and to temporarily increase local blood circulation. |
1
Care Electronics, Inc.
Dermillume Red 501(k) Submission
051681
510(k) Summary, contd.
The performance data obtained from bench testing of the Performance Data: Dermillume lamp substantiates that the irradiance at a practicable distance from the skin surface is comparable with the cited predicated lamps.
The mode of operation, technology and general principles of this lamp are the same as the predicate lamps.
There are no significant adverse reactions observed in clinical studies using this technology. The lamp is safe and efficacious.
The Dermillume Red HR1000 infrared lamp is substantially Substantial Equivalence: equivalent to the cited predicate lamps for spectral output, mode of operation, operating principals as well as general and specific indications for use. Although there are some differences in the source of the emitted light and output intensity, these differences are minor and do not raise new questions of safety or efficacy.
The Dermillume Red HR1000 infrared lamp is substantially equivalent.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, representing healing and medicine. The caduceus is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 27 2005
Mr. Thomas O. Moody President Care Electronics, Inc. 4700 Sterling Drive, Suite D Boulder. Colorado 80301
Re: K051681
Trade/Device Name: Dermillume Red, model HR 1000 Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: ILY Dated: July 8, 2005 Received: July 12, 2005
Dear Mr. Moody:
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.
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Page 2- Mr. Thomas O. Moody
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 (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 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,
Stypt Rlvodlee
Mark N. Melkerson, MS Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K051681
Lamp Name: Dermillume Red, model HR1000
Indications for Use: The Dermillume Red HR1000 infrared lamp is intended for the relaxation of muscles and relief of muscle spasms, temporary relief of minor muscle and joint aches, pains and stiffness, temporary relief of minor pain and stiffness associated with arthritis, and to temporarity increase local blood circulation.
Prescription Use . Yes (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use Yes (21 CFR 807 Subpart C)
(Please Do Not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Lamp Evaluation (ODE)
Styt Rurda
ign-Off (Division Division of General, Restorative, and Neurologica! Devices
510(k) Number K051681