(60 days)
Not Found
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The device description is purely physical (laser).
Yes
The device is indicated for adjunctive use in the temporary relief of hand and wrist pain associated with Carpal Tunnel Syndrome, which is a therapeutic purpose.
No
The device is indicated for temporary pain relief, not for diagnosing a condition.
No
The device description explicitly states it is a "non thermal triple diode infrared laser," which is a hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "temporary relief of hand and wrist pain associated with Carpal Tunnel Syndrome." This describes a therapeutic application, not a diagnostic one. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The device is described as a "non thermal triple diode infrared laser." This is a physical therapy device, not a device designed to analyze biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as analyzing blood, urine, tissue, or other biological specimens.
Therefore, the Axiom BioLaser LLLT Series-3 is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Axiom BioLaser LLLT Series-3 is indicated for adjunctive use in the temporary relief of hand and wrist pain associated with Carpal Tunnel Syndrome.
Product codes
NHN
Device Description
The Axiom Bio LLLT Series -3 is a non thermal triple diode infrared laser.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand and wrist
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
0
AXIOM WORLDWIDE
NOV 25 2003
510 (k) Summary
033015 1 of 1
| Device
Classification
Name | Lamp, Non-heating for
Adjunctive use in pain therapy |
|----------------------------------|---------------------------------------------------------|
| Regulation Number | 890.5500 |
| 510(k) Number | K033015 |
| Device Name | The Axiom BioLaser LLT Series - 3 |
Power Laser 90 - K030692 Substantially Equivalence Micro Light ML830 K010175
Applicant
Axiom Worldwide 9423 Corporate Lake Drive
Tampa, Florida 33634
| Contact | James J. Gibson Telephone 813-249-6444 fax 813-249-6445 |
|---|---|
| Product Code | NHN |
| Date Received | September 26th 2003 |
| Device Description | The Axiom Bio LLLT Series -3 is a non thermal triple diode |
| infrared laser. | |
| Intended Use | The Axiom BioLaser LLLT-3 is indicated for adjunctive use in |
| temporary relief of hand and wrist pain associated with Carpal | |
| Tunnel Syndrome |
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines that suggest the head, body, and tail feathers.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 25 2003
Mr. James J. Gibson, Jr. President and CEO Axiom USA, Inc. 9423 Corporate Lake Drive Tampa, Florida 33634
Re: K033015
Trade/Device Name: Axiom BioLaser LLLT Series-3 Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: NHN Dated: September 26, 2003 Received: October 3, 2003
Dear Mr. Gibson:
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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 - Mr. James J. Gibson, Jr.
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 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours,
Miriam C. Provost
for
Sadie M. White, Ph.D., M.D.
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
3
510(k) Number (if known): K033015
Device Name: Axiom BioLaser LLLT Series-3
Indications For Use:
Intended Use
The Axiom BioLaser LLLT Series-3 is indicated for adjunctive use in the temporary relief of hand and wrist pain associated with Carpal Tunnel Syndrome.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use ----------
Miriam C. Provost
Division of General, Restorative and Neurological Devices
510(k) Number K033015