LUMIWAVE 1X4 INFRARED THERAPY DEVICE

K051816 · Biocare Systems, Inc. · ILY · Aug 26, 2005 · Physical Medicine

Device Facts

• Record ID: K051816
• Device Name: LUMIWAVE 1X4 INFRARED THERAPY DEVICE
• Applicant: Biocare Systems, Inc.
• Product Code: ILY · Physical Medicine
• Decision Date: Aug 26, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

LumiWave 1X4 is an OTC infrared therapy device; utilizes 4 pods, each containing 49 GaAlAs LEDs; emits infrared energy (880-893 nm) to elevate tissue temperature. Device operates via thermal control circuits to regulate skin temperature. Intended for home use by patients for pain relief and increased local circulation. Output is topical heat; healthcare providers or patients use device to manage minor musculoskeletal pain and arthritis-related symptoms. Benefits include temporary pain reduction and improved circulation.

Clinical Evidence

No clinical data provided. Performance data is limited to bench testing of energy delivery (12-56 mW/cm²) and wavelength distribution (822-941 nm range). Electrical safety and electromagnetic compatibility verified via EN 60601-1 and EN 60601-1-2 standards.

Technological Characteristics

Infrared lamp (21 CFR 890.5500); 4 pods with 49 GaAlAs LEDs each; wavelength 880-893 nm; energy delivery 12-56 mW/cm²; thermal control circuit for skin temperature regulation; electrical safety per EN 60601-1; EMC per EN 60601-1-2.

Indications for Use

Indicated for temporary relief of minor muscular pain, back pain, joint pain, stiffness, muscle spasms, and sub-acute or chronic pain associated with arthritis, sprains, or strains; intended to increase local blood circulation via tissue heating.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• BioCare System's PremIR 818 (K042532)

Submission Summary (Full Text)

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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<br>518 17th Street<br>Suite 1350<br>Denver, CO 80202 |
|--------------------------------|--------------------------------------------------------------------------------------------------|
| 510(k) contact name / numbers: | Clay Anselmo<br>Phone: [phone] or 303.223.4303<br>Fax: [phone]<br>[e-mail] |
| 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

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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.

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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.

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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 [phone]. 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 [phone] 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

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# 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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