(52 days)
Not Found
No
The summary describes a simple infrared therapy device with LEDs and does not mention any AI or ML components or functionalities.
Yes
The device is intended for the temporary relief/reduction of various types of pain (muscular, joint, back pain, muscle spasms, arthritis, sprains/strains) and to temporarily increase local blood circulation, which are therapeutic claims.
No
The device is described as an infrared therapy device intended to provide temporary relief of pain and increase local blood circulation. Its "Intended Use" and "Device Description" sections focus on therapeutic effects (elevating tissue temperature, pain relief, increased circulation) and do not mention any diagnostic functions such as detection, analysis, or measurement of a condition.
No
The device description explicitly details hardware components (4 pods, 49 LEDs per pod) that emit infrared light for therapy, indicating it is a physical device, not software-only.
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 therapeutic purposes, specifically for pain relief, increased blood circulation, and relief of muscle spasms. It acts on the body directly.
- Device Description: The device description details how it emits infrared light to heat tissue, which is a physical therapy mechanism, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a disease or condition.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
BioCare system's infrared therapy products emit energy in the infrared spectrum for the purposes of elevating tissue temperature; for temporary relief / reduction of minor muscular pain, minor muscular back pain and minor joint pain and stiffness. Additionally, these products are intended to provide a temporary increase in local blood circulation and provide temporary relief of muscle spasms and minor sub-acute or chronic pain associated with arthritis, sprains or strains.
Product codes (comma separated list FDA assigned to the subject device)
ILY
Device Description
The LumiWave 1X4 Infrared Therapy Device is an over-the-counter, infrared-therapy device, designed to emit energy at infrared frequencies to provide topical heating. The LumiWave 1X4 Infrared Therapy Device provides infrared therapy through the use of an efficient and easy to use set of 4 small pods that delivers infrared light for the purpose of elevating tissue temperature to treat living tissue in the body. Infrared light is delivered to the tissue through 49 Gallium Aluminum Arsenide (GaAlAs) Light Emitting Diodes (LEDs) (per pod) distributed under the each pod cover of the LumiWave 1X4 Infrared Therapy Device. The LEDs used in the LumiWave 1X4 Infrared Therapy Device have average wavelengths of between 880 nm and 893 nm depending on temperature.
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)
The Thermal control circuit in each pod provide for regulation of skin temperatures to between 40 degrees C (in HIGH Mode) and 42 degrees C (in LOW Mode).
Complies with EN 60601-1-2, Electromagnetic Compatibility
Complies with EN 60601-1, General Electrical Safety
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
K05/8/6
9. 510(k) Summary
510(k) SUMMARY BIOCARE SYSTEMS, INC - LumiWave 1X4 Infrared Therapy Device
SUBMITTER INFORMATION
| Company name / address: | Regiera LLC
518 17th Street
Suite 1350
Denver, CO 80202 |
|--------------------------------|--------------------------------------------------------------------------------------------------|
| 510(k) contact name / numbers: | Clay Anselmo
Phone: 800-341-4255 or 303.223.4303
Fax: 303-832-6700
anselmoc@reglera.com |
| Date summary prepared: | 6/9/05 |
| DEVICE IDENTIFICATION | |
| Trade names: | LumiWave 1X4 Infrared Therapy Device |
| Common name: | LumiWave 1X4 Infrared Therapy Device |
Infrared Lamp Classification name:
MODIFIED FROM DEVICE:
Trade name: BioCare System's PremIR 818 510(k) number: K042532
DEVICE DESCRIPTION
The LumiWave 1X4 Infrared Therapy Device is an over-the-counter, infrared-therapy device, designed to emit energy at infrared frequencies to provide topical heating. The LumiWave 1X4 Infrared Therapy Device provides infrared therapy through the use of an efficient and easy to use set of 4 small pods that delivers infrared light for the purpose of elevating tissue temperature to treat living tissue in the body. Infrared light is delivered to the tissue through 49 Gallium Aluminum Arsenide (GaAlAs) Light Emitting Diodes (LEDs) (per pod) distributed under the each pod cover of the LumiWave 1X4 Infrared Therapy Device. The LEDs used in the LumiWave 1X4 Infrared Therapy Device have average wavelengths of between 880 nm and 893 nm depending on temperature.
INDICATIONS FOR USE
BioCare System's infrared therapy products emit energy in the infrared spectrum for the purposes of elevating tissue temperature; for temporary relief / reduction of minor muscular pain, minor muscular back pain and minor joint pain and stiffness. Additionally, these products are intended
1
to provide a temporary increase in local blood circulation and provide temporary relief of muscle
r and the started in the same in the deville attrains anrains or strains to provide a temporary increase in local blood ordailer and provided with arthritis, sprains or strains.
spasms and minor sub-acute or chronic pain associated with arthritis,
TECHNOLOGICAL CHARACTERISTICS COMPARISON
The following primary characteristics of the LumiWave 1X4 Infrared Therapy Device are THC following quivalent to the BioCare PremIR 818.
- Indications for Use ●
- Wavelength of the diode utilized .
- Waveform .
- Power supply and specifications .
- Energy source .
- Device type .
- Delivered energy per unit area .
PERFORMANCE DATA
12 – 56 mW/cm² Delivered Energy:
| HIGH Mode | LOW Mode | |
|---|---|---|
| Central Wavelength: | 900 nm | 899 nm |
| Mean Wavelength: | 893 nm | 890 nm |
| Minimum Wavelength: | 824 nm | 822 nm |
| Maximum Wavelength: | 941 nm | 934 nm |
Note: maximum and minimum wavelengths were calculated using the area under the distribution which contains 99.7% of the population (+/- 3 sigma)
Complies with EN 60601-1-2, Electromagnetic Compatibility Complies with EN 60601-1, General Electrical Safety
The Thermal control circuit in each pod provide for regulation of skin temperatures to between 40 The Themial Control Circuit in Cach pour provide in Togalation of C in LOW Mode).
CONCLUSION
The LumiWave 1X4 Infrared Therapy Device is substantially equivalent to the device it was modified from, the PremIR 818.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its wings or feathers.
Public Health Service
AUG 2 6 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
BioCare Systems, Inc. c/o Mr. Clay Anselmo Reglera LLC 518 17th Street, Suite 1350 Denver, Colorado 80202
Re: K051816
R051010
Trade/Device Name: LumiWave 1X4 Infrared Therapy Device Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: ILY Dated: August 16, 2005 Received: August 17, 2005
Dear Mr. Anselmo:
We have reviewed your Section 510(k) premarket notification of intent to market the indication we have reviewed your becaon 910(x) premier is substantially equivalent (for the indications felerenced above and nave decemblicate devices marketed predicate devices marketed in interstate for use stated in the enclosure) to tegans annent date of the Medical Device Amendments, or to commerce proc to May 20, 1976, the encordance with the provisions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA). and Cosment Act (Act) that do not require app o the general controls provisions of the Act. The Y ou may, merciole, market the device, ich include requirements for annual registration, listing of general controls provisions of the free 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 classified (soc aboro) xils. Existing major regulations affecting your device can may be subject to such additional controller L. Ribbing of Parts 800 to 898. In addition, FDA may oe found in the Oous neements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please oc advised that I Dri s issualite of our device complies with other requirements of the Act that I Dri has made a acterimisations administered by other Federal agencies. You must of any recetal statures and regalations and and limited to: registration and listing (21 comply with an the Not 8 requirements) 01); good manufacturing practice requirements as set CFR in 1 or 7, adoling (21 OFR Part 820); and if applicable, the electronic ford in the quality bystello (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will allow you to begin nakemig your antial equivalence of your device to a legally
premarket notification. The FDA finding of sybstantial end this permits vour premarket notification. The PDA Inding of substantial organity of the succession for your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
rst led If you desire specific advice for your de vice of tour its . Also, please note the regulation entitled,
contact the Office of Compliance at (240) 276-0115. Also, please note contact the Office of Compliance at (240) 276 - 1 - 1 - (217) Part 807.97). You may obtain
"Misbranding by reference to premarket notification the Oxycision of Small "Misbranding by reference to premarks notified.com the Act from the Division of Small
other general information on your responsibilities under the Act first number (800) 638other general information on your responsionities and areas and areas and or (800) 638-2041 or
Manufacturers, International and Consumer Assistance at its toll-idemanain html Manufacturers, International and Consumer Heelswafdagov/cdrh/dsma/dsmamain.html
Sincerely yours,
Signature
Mark N. Melkerson S 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): ____________________________________________________________________________________________________________________________________________________
Device Name: LumiWave 1X4 Infrared Therapy Device_____________________________________________________________________________________________________________________________
Indications for Use:
BioCare system's infrared therapy products emit energy in the infrared spectrum for the BloCare system's imfarca therapy products chappersy relief / reduction of minor
purposes of elevating tissue temperature; for temporary relief / reductiff ass purposes of elevating tissue tomperature, roin and minor joint pain and stiffiess.
muscular pain, minor muscular back pain and minor joint pain and stiffiness. muscular pain, minor muscular vack pain and miner 3 semporary increase in local blood
Additionally, these products are intent as a sense miner sub acute or Additionally, these products are mirelief of muscle spasms and minor sub-acute or chronic pain associated with arthritis, sprains or strains.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use xxx (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE
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(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
(Posted November 13, 2003)
| LumiWave 1X4 Infrared Therapy Device 510(k) | 510(k) Number K051816 |
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