(134 days)
Not Found
No
The summary describes a simple laser device and explicitly states "Not Found" for mentions of AI, DNN, or ML, and lacks any description of training or test sets, which are typical for AI/ML devices.
Yes
The Device Description explicitly states: "The POWER LASER 90 is a hand-held, battery operated, non-invasive, non-thermal, low energy, infrared laser, therapeutic medical device."
No
The device is described as a "therapeutic medical device" used for "temporary relief of hand and wrist pain," indicating a treatment function, not a diagnostic one.
No
The device description explicitly states it is a "hand-held, battery operated, non-invasive, non-thermal, low energy, infrared laser, therapeutic medical device," indicating it is a physical hardware device that emits laser energy.
Based on the provided information, the POWER LASER 90 is not an IVD (In Vitro Diagnostic) device.
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 description clearly states it's a "therapeutic medical device" that is "non-invasive" and uses a laser for treatment.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing information about a patient's health status based on in vitro testing.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. The POWER LASER 90 directly interacts with the body for therapeutic purposes.
N/A
Intended Use / Indications for Use
The POWER LASER 90 is indicated for adjunctive use in the temporary relief of hand and wrist pain associated with Carpal Tunnel Syndrome.
Product codes (comma separated list FDA assigned to the subject device)
NHN
Device Description
The POWER LASER 90 is a hand-held, battery operated, non-invasive, non-thermal, low energy, infrared laser, therapeutic medical device. A separate battery charger can recharge the battery when it is removed from the POWER LASER 90. POWER LASER 90 is a finished device, which is delivered packed with battery charger and complete labeling for the user.
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
professional use
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): 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
510(k) Summary as required by section 807.92(c) JUL 17 2003
Submitted by: ANDI electromedical ApS Parallelvej 2, DK-4300 Holbek Phone: 01145 5944 0832 Fax: 01145 5944 2911 Arne Grinsted Contact Person: Prepared On: February 28, 2003 Lamp, Infrared Classification Name: Common Name: Infrared Laser
Proprietary Name:
Classification:
The device satisfies the 21 CFR definition of a Class II infrared lamp as follows:
| Regulation | Classification | Product | Identification / Classification |
|---|---|---|---|
| Number | Number | Nomenclature | |
| 890.5500 | ILY | Lamp, Infrared | A device that emits energy at |
| infrared frequencies | |||
| (approximately 700 nanometers) | |||
| to 50,000 nanometers to provide | |||
| topical heating |
POWER LASER 90
| Establishment registration: | Owner / Operator No: 9052408 | |
|---|---|---|
| US Representative: | National Medical Alliance | |
| 12415 Old Meridian St. | ||
| Carmel, IN 46032 | ||
| Tel: 800-662-7283 | ||
| Contact person: Jeff Worrell | ||
| Development: | ANDI electromedical ApS has developed the device. | |
| Production: | ANDI electromedical ApS is manufacturing and | |
| packaging the device. | ||
| Reason for the 510(k): | The Product has never been marketed in USA before. | |
| However the POWER LASER range has been | ||
| marketed in Europe since 1998. The product, which is | ||
| for professional use, is used for therapy. |
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4
Substantial Equivalence: POWER LASER 90 is substantially equivalent to the Micro light 830, which was the subject of 510(k) number K010175. The POWER LASER 90 has the equivalent intended use (i.e. pain relief). Device Description: The POWER LASER 90 is a hand-held, battery operated, non-invasive, non-thermal, low energy, infrared laser, therapeutic medical device. A separate battery charger can recharge the battery when it is removed from the POWER LASER 90. POWER LASER 90 is a finished device, which is delivered packed with battery charger and complete labeling for the user. Special Controls: The POWER LASER 90 as well as the battery charger demonstrates compliance to relevant safety-standards, EMC standards and standards for laser equipment. The POWER LASER 90 is indicated for adjunctive use Statement of Indications for use: in the temporary relief of hand and wrist pain associated with Carpal Tunnel Syndrome.
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 17 2003
Mr. Arne Grinsted President ANDI electromedical Aps Parallelvej 2, DK-4300 Holbeck
Re: K030692
Trade/Device Name: Power Laser 90 Regulation Number: 21 CFR 890.5500 Regulation Name: Lamp, non-heating, for adjunctive use in pain therapy Regulatory Class: II Product Code: NHN Dated: May 23, 2003 Received: May 27, 2003
Dear Mr. Grinsted:
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 (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 - Mr. Arne Grinsted
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. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained 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 yours,
Muriam C Provost
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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Page J of I
510(k) Number (if known): K030692
Device Name: POWER LASER 90
Indications For Use: The POWER LASER 90 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)
(Optional Format 3-10-98)
Muriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K030692