(19 days)
Not Found
No
The document describes a laser system for pain relief and does not mention any AI or ML components or functionalities.
Yes
The device is explicitly described as a "therapeutic medical laser" and its intended use is for "temporary relief of hand and wrist pain," which are both therapeutic purposes.
No
The device is described as a "therapeutic medical laser" intended for "adjunct use in the temporary relief of hand and wrist pain." It does not mention any function related to diagnosing medical conditions.
No
The device description explicitly states it is a "handheld, non-invasive, low energy, nonheating infrared therapeutic medical laser" and details its hardware components (laser diodes, wavelength, power output). This indicates 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 is for the temporary relief of hand and wrist pain associated with Carpal Tunnel Syndrome. This is a therapeutic application, not a diagnostic one.
- Device Description: The device is a therapeutic laser system that delivers energy to the body. It does not analyze biological samples (like blood, urine, or tissue) to provide diagnostic information.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples
- Detecting biomarkers
- Providing diagnostic results
Therefore, the THØR DDII 830CL3 Laser System is a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The THØR DDII 830CL3 Laser System is a non-heating infrared lamp and is indicated for adjunctive use in the temporary relief of hand and wrist pain associated with Carpal Tunnel Syndrome.
Product codes
NHN
Device Description
THØR DDII 830CL3 Laser System is a handheld, non-invasive, low energy, nonheating infrared therapeutic medical laser that is intended for use as an adjunct treatment for managing the temporary relief of pain associated with Carpal Tunnel Syndrome. The THØR 830CL3 Laser System incorporates three 30 milliwatt (mW) Gallium Aluminum Arsenide (GaAlAs) laser diodes delivering a total output power of 90 milliwatts (mW) at 830 nanometer (nm) wavelength.
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
Testing of the THØR DDII 830CL3 Laser System included functional performance testing and electrical safety testing.
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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Image /page/0/Picture/0 description: The image shows the text "K030226 1/2" written in black ink on a white background. The text appears to be handwritten and is slightly slanted. The numbers and letters are clearly legible, and the overall image is simple and straightforward.
510(k) Notification THØR DDII 830CL3 System January 20, 2003
APPENDIX C SUMMARY OF SAFETY AND EFFICACY
510(k) PREMARKET NOTIFICATION SUMMARY
FEB 1 0 2003
(per 21 CFR 807.92)
THØR DDII 830CL3 Laser System
I. Applicant:
THØR International Ltd. Caer Sidhe Chiltern Road Amersham HP6 5PH United Kingdom Telephone: +44 1494 433 736 +44 1494 431 481 Facsimile: James Carroll Contact: james@thorlaser.com e-mail M. Joyce Heinrich Contact Person: Texas Applied Biomedical Services, Inc. 12101 Cullen Blvd., # A Houston, Texas 77047 713 / 734-4433 telephone 713 / 734-5671 facsimile
II. Device Name:
| Proprietary Name: | THØR DDII 830CL3 Laser System |
|---|---|
| Common / Usual Name: | Low Level Laser System |
| Classification Name: | Infrared Lamp (21 CFR 890.5500) |
| Product Code: | NHN |
tabs1@tabs.net e-mail
III. Predicate Device
THØR DDII 830CL3 Laser System is substantially equivalent to other low level therapeutic lasers currently in commercial distribution. These predicate devices include the MicroLight Corporation of America, Inc. MicroLight 830 Laser System (K010175), Acculaser, Inc. Acculaser Pro Low Level Laser System (K020657) and the MedX LCS System (K021985). These devices were cleared for introduction into interstate commerce via the FDA's 510(k) Notification process. The Therapeutic Laser System has the same intended use as and similar technological characteristics to these predicate devices.
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030226 2/2
IV. Intended Use of the Device
The THØR DDII 830CL3 Laser System is a non-heating infrared lamp and is indicated for adjunctive use in the temporary relief of hand and wrist pain associated with Carpal Tunnel Syndrome.
V. Description of the Device
THØR DDII 830CL3 Laser System is a handheld, non-invasive, low energy, nonheating infrared therapeutic medical laser that is intended for use as an adjunct treatment for managing the temporary relief of pain associated with Carpal Tunnel Syndrome. The THØR 830CL3 Laser System incorporates three 30 milliwatt (mW) Gallium Aluminum Arsenide (GaAlAs) laser diodes delivering a total output power of 90 milliwatts (mW) at 830 nanometer (nm) wavelength.
Summary of the technical characteristics of the THØR DDII 830CL3 Laser VI. System to the referenced predicate device.
The THØR DDII 830CL3 Laser System and the aforementioned predicate devices are non-heating infrared lamps as defined in 21 CFR 890.5500. These devices use infrared diodes to emit invisible photonic energy to tissue. The intended use is identical for all devices.
VII. Testing
Testing of the THØR DDII 830CL3 Laser System included functional performance testing and electrical safety testing.
The THØR DDII 830CL3 Laser System is manufactured to comply with the following European standards:
Medical Electrical Equipment Medical Laser Equipment EMC CE Marking Classification Medical Device Directive
EN60601-1: 1993 EN 60601-2-22:1996 EN60601-1-2: 1994 IIb, Certificate No. C10151 issued by SGS 93/42/EEC Annex II
VIII. Conclusions
Pursuant to the testing and comparison to the predicate devices, the THØR DDII 830CL3 Laser System has the same intended uses, with similar functional and performance characteristics. The System is designed to comply with the generally accepted therapeutic laser performance specifications as an adjunctive treatment for the relief of hand and wrist pain associated with Carpal Tunnel Syndrome.
THØR DDII 830CL3 Laser System performs as intended and does not raise any new safety or efficacy issues.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight.
Public Health Service
FEB 1 0 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
THOR International Ltd. c/o M. Joyce Heinrich Regulatory Consultant Texas Applied Biomedical Services, Inc. 12101 A Cullen Boulevard Houston, Texas 77047
Re: K030226
Trade Name: THOR DDII 830CL3 Laser System Regulation Number: 21 CFR 890.5500 Regulation Name: Lamp, Non-Heating for Adjunctive Use in Pain Therapy Regulatory Class: II Product Code: NHN Dated: January 17, 2003 Received: January 22, 2003
Dear Ms. Heinrich:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 - M. Joyce Heinrich
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.
Sincerely yours,
Mark A. Milliman
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
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APPENDIX B
STATEMENT OF INDICATIONS FOR USE
STATEMENT FOR INDICATIONS FOR USE
Pending KO30226 510(k) Number (if known):
THØR DDII 830CL3 Laser System Device Name:
Indications for Use:
The THØR DDII 830CL3 Laser System 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)
OR Over the Counter Use Prescription Use: (Optional Format 1-2-96) (per 21 CFR801.109) (Division Sign-Off) 510(k) Number _ េរោ Sivision of General Dosto Juve Jugical Devices 10(k) Number _________________________________________________________________________________________________________________________________________________________________