(362 days)
Not Found
No
The description focuses on the physical mechanism of action (infrared light from LEDs) and does not mention any computational or data-driven processes characteristic of AI/ML.
Yes.
The device's intended use is to provide temporary relief of pain and stiffness, promote relaxation, and improve range of motion, which are therapeutic benefits.
No
The device provides therapeutic heat for pain relief and increased blood flow, but it does not diagnose any condition. Its function is to provide therapy, not to identify or monitor a disease state.
No
The device description explicitly states the devices are "electrical and mechanical designs" and generate heat using "LEDs (light emitting diodes)," indicating a hardware component is essential to its function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide infrared light energy for therapeutic purposes (pain relief, increased blood flow, etc.) by applying it to the skin. This is a physical therapy or medical device function, not a diagnostic one.
- Device Description: The device is an infrared lamp that generates heat. This is a physical device, not something that analyzes biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, 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
To provide infrared light energy that penetrates the skin to promote increased blood flow and circulation, thereby, providing temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, and muscle spasm. The elevated tissue temperature also promotes relaxation of muscles and relief from pain resulting in improved range of motion
Product codes
ILY
Device Description
The devices are a family (models) of infrared lamps having the same indication for use and equivalent technology. The units are electrical and mechanical designs for use and convenience of users to provide topical heating. Heat is generated by LEDs (light emitting diodes) at 940 nm wavelength.
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
A Risk Analysis was performed on all models using EN1441. Potential hazards are identified and have been mitigated by design and labeling.
The devices were tested for performance and found to raise skin temperature safely when used following the manufacturer's instructions. The rise in skin temperature results in the indications for use.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Ko24027
510(k) Summary Infrared Lamp, Models LW10D and LW30D
Skytech Enterprises, Inc. 2425 N.W. 69th Street Vancouver, WA 98665 360-699-6194 Telephone 360-699-6197 Fax Douglas Greene, Chairman
Prepared 11/25/02 by: L.W. Ward and Associates, Inc. 4655 Kirkwood Court Boulder, CO 80301 303-530-3279 Telephone 303-530-4774 Fax
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Device: LightWave™ Infrared Photon Stimulator, Models, LW10D and LW30D
Common Name: Infrared Lamp
Classification: 890.5500, 89 ILY, Class II
SE Predicates:
- a) C&H International K020851, Infrared Heating Lamp TDP Heat Lamp
- b) BioScan, Inc. K993684, Infrared Lamp Spinal Pad
Device Description:
The devices are a family (models) of infrared lamps having the same indication for use and equivalent technology. The units are electrical and mechanical designs for use and convenience of users to provide topical heating. Heat is generated by LEDs (light emitting diodes) at 940 nm wavelength. .
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| Model | Number of LEDs | Output Power | Wavelength | Power Source | Light Pattern | Treatment Area | Battery Life | Recommended Treatment |
|---|---|---|---|---|---|---|---|---|
| LW10D | 9 | 20 mW | 940 nm | 9V DC battery or 110V AC/9V DC adapter | 145 Hz pulse | ~225 square mm | 6 hours continuous | 15 minutes |
| LW30D | 30 | 30 mW | 940 nm | 110V AC/9V DC adapter only (no battery) | 145 Hz pulse | ~900 square mm | 30 hours pulsing N/A | 10 minutes |
Tech Infrared Photon Stimulator Model Differentiati
ntended Lise:
If orovide intract light ears the skin o promote increased blood for and circulation, thereby, providing
emprary relef of minor musele ad join pain resulting n
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SE Comparison:
Comparative Information
:
| Model LW10D | Model LW30D | TDP Infrared Lamps
K020851 | The LightPatch
K993684 |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ILY
Skytech | ILY
Skytech | ILY
C&H Intl.
Houston, TX | ILY
BioScan, Inc.
Corrales, NM |
| Infrared light
energy to promote
increased blood
flow and circu-
lation, providing
temporary relief of
minor muscle and
joint pain and
stiffness, minor
arthritis pain, and
muscle spasm.
Promotes
relaxation of
muscles and relief
from pain resulting
in improved range
of motion. | Infrared light
energy to promote
increased blood
flow and circu-
lation, providing
temporary relief of
minor muscle and
joint pain and
stiffness, minor
arthritis pain, and
muscle spasm.
Promotes relaxation
of muscles and
relief from pain
resulting in
improved range of
motion. | Temporary relief of
minor muscle and
joint pain and
stiffness, the
temporary relief of
minor joint pain
associated with
arthritis, the temporary
increase in local
circulation where
applied, and relaxation
of muscles. Help
muscle spasms, minor
sprains, and minor
muscular back pain. | Personal comfort,
temporary relief of
minor aches and pains
in muscles and joints.
Aids in relaxation in
muscles, temporary
infrared range and
freedom of motion,
temporary minor pain
relief, temporary
increase in local blood
circulation. |
| Yes | Yes | Yes | Yes |
| Yes | Yes | Yes | Yes |
| 9V DC battery or
110V AC adapter,
UL listed | 110V AC adapter
(only), UL listed | 110V AC | 9V DC battery |
| 940 nm | 940 nm | 940 nm | 940 nm |
| ~225 square mm | ~900 square mm | ~1215 square mm | ~6500 square mm |
:
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510(k) Substantial Equivalence Rationale:
-
- The Skytech devices have the same indications for use as the predicate devices, TDP Infrared Lamp and the LightPatch.
- The same technological characteristics are used for this device and the two 2. predicates. All are based on the mode of operation that light emitting diodes convey heat energy to the skin. The device LEDs all operate at 940nm.
-
- The comparative information shown in this submission demonstrates substantial equivalence for indications for use, design, and mode of operation.
Nonclinical Data:
A Risk Analysis was performed on all models using EN1441. Potential hazards are identified and have been mitigated by design and labeling.
The devices were tested for performance and found to raise skin temperature safely when used following the manufacturer's instructions. The rise in skin temperature results in the indications for use.
Adapters to convert 110V power to 9V or 12V are UL listed to assure user safety.
Conclusions:
These infrared lamp models are designed, labeled, and verified for performance and safety. The design has been tested and verified to raise the skin temperature adequately to effect the indications for use. A Risk Analysis confirms the design process and final product design for consideration of potential hazards. The potential hazards have been adequately addressed and mitigated by the design or by labeling. Labeling covers the user instructions and warning statements for users.
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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. 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 emblem featuring three wavy lines that resemble an abstract representation of the American flag.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 3 2003
Skytech Enterprises, Inc. C/o Mr. Lewis Ward L.W. Ward and Associates, Inc. 4655 Kirkwood Court Boulder, Colorado O 80301
Re: K024027
Trade/Device Name: Lightwave Infrared Lamps LW10D and LW30D Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: ILY Dated: October 15, 2003 Received: October 21, 2003
Dear Mr. Ward:
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 for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreations of the enactment date of the Medical Device Amendments. or to commerce proc to May 20, 1978, the enoveance with the provisions of the Federal Food, Drug, devices mat have been rechtsined in quire approval of a premarket approval application (PMA). and Cosmetter (110) that Lo neview, subject to the general controls provisions of the Act. The Tou may, dierettle, mains of the Act include requirements for annual registration, listing of general controls profitation 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 elassinod tional 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 I lease be advised that I Drivisante a vour device complies with other requirements of the Act that I Dri has intact and regulations administered by other Federal agencies. You must or any I catal states and registanents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI K Lat 007); adoling (Dr OS) regulation (21 CFR Part 820); and if applicable, the electronic ford in the quarty by wisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Lewis Ward
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotter will and wy and finding of substantial equivalence of your device to a legally premance hotification. 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 spocific acrios 101 your as (301) 594-4659. Also, please note the regulation entitled, Connact the Office of Comments 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 general informational 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
Sincercly yours,
Mark N Millerm
Celia M. Witten, PhD, MD Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Initial 510(k):
Device Name:
Indications for Use:
Janf
To provide infrared light energy that penetrates the skin to promote increased 1 of provide and circulation, thereby, providing temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, and muscle spasm. The elevated tissue temperature also promotes relaxation of muscles and relief from pain resulting in improved range of motion
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
ision Sign-Off)
ision of General, Restorative
and Neurological Devices
Number. K024027
Prescription Use __ OR Over-the-Counter Use X
(Per 21 CFR 801.109)
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