(256 days)
No
The document describes a laser system for heat therapy with fixed frequency and continuous output, with no mention of adaptive algorithms, learning, or data processing that would indicate AI/ML.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is for "temporary relief of minor muscle and joint aches, pains, and stiffness," which are therapeutic applications. Additionally, the "Device Description" refers to it as "therapeutic medical laser systems."
No
The device is described as a "therapeutic medical laser system" used to provide "topical heating" for "temporary relief" of various pains and stiffness. It does not mention any diagnostic capabilities or functions.
No
The device description clearly outlines hardware components such as a control unit, power supply, laser modules, and fiber optics, indicating it is a physical medical 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 clearly describes a therapeutic device that provides topical heating for pain relief and muscle relaxation. This involves direct interaction with the patient's body for treatment purposes.
- Device Description: The description details a laser system designed to deliver light energy to tissue. This is consistent with a therapeutic device, not a device used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting substances, or providing diagnostic information based on in vitro analysis.
IVD devices are used to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is entirely therapeutic and involves direct application to the patient.
N/A
Intended Use / Indications for Use
The weberneedle@basic laser is indicated to provide topical heating for the following:
- · temporary increase of local blood circulation.
- · temporary relief of minor muscle and joint aches, pains, and stiffness.
- · temporary relaxation of muscles.
- · temporary relief of muscle spasms.
- · temporary relief of minor pain and stiffness associated with arthritis.
Product codes
ILY
Device Description
The weberneedle®basic laser and the weberneedle®basic "compact edition" laser are non-invasive, portable therapeutic medical laser systems designed to deliver light energy to the target tissue. The red and infrared lamps provide continuous heat therapy at a fixed frequency. The System operates by AC power and is used with 8 up to 12 faser modules, as standard 4 red and 4 infrared modules. The system consists of a Control Unit / Power Supply that houses the electronics and controls the power and varies the frequency of the each laser module. The weberneedle®basic laser and the weberneedle®basic "compact edition" laser are equipped with single fibre optics to bring the emitted energy to the tissue. That allows treatment either of small or of expanded pain areas as well as both at the same time.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing of the System includes functional performance testing and electrical safety testing.
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.
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AUG 11 2008
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Waber Medical GmbH Germany weberneedle@basic laser, 510(k) Notification June 1901. 2008
5. 510(k) PREMARKET NOTIFICATION SUMMARY
(as per 21 CFR Part 807.92)
I. Applicant:
Weber Medical GmbH Sohnreystrasse 6 37697 Lauenförde GERMANY
Tel.: +49 5273 36778 - 0 Fax: +49 5273 36778 - 19 Email: weber@webermedical.com
Pf
Or
Stlu
Key Contact: Dr. med. Dipl. Chem. Michael Weber (Chairman)
II. Device Name
Proprietary Name:
weberneedle@basic laser weberneedle@basic "compact edition" laser Infrared Lamp Class II, Infrared Lamp (21 CFR 890.5500) ILY
Product Code:
Common / Usual Name:
Classification Name:
III. Intended Use of the Device
The weberneedle@basic laser is indicated to provide topical heating for the following:
- · temporary increase of local blood circulation.
- · temporary relief of minor muscle and joint aches, pains, and stiffness.
- · temporary relaxation of muscles.
- · temporary relief of muscle spasms.
- · temporary relief of minor pain and stiffness associated with arthritis.
IV. Predicate Device
The weberneedle®basic laser and the weberneedle®basic "compact edition" laser are substantially equivalent to other infrared therapeutic lamps that are currently in commercial distribution. Representative predicate devices to the weberneedle@basic laser and the weberneedle®basic "compact edition" laser include, but are not limited to, the Thor Int. DDII Laser System (K033923) and the Chattanooga Group Vectra Genisys Laser System (K040662). These
weber medical GmbH · HRB 101161 HOL · Registergericht Holzminden Bankverbindung: Commerzbank Holzminden · BLZ: 272 400 04 · Kontonummer: 58 00 610
1
pg 2 of 3
Weber Medical GmbH. Germany weberneedle@basic laser, 510(k) Notification Juna 19 2008
devices were cleared for introduction into interstate commerce via the FDA's 510(k) Notification Process.
V. Description of the Device
The weberneedle®basic laser and the weberneedle®basic "compact edition" laser are non-invasive, portable therapeutic medical laser systems designed to deliver light energy to the target tissue. The red and infrared lamps provide continuous heat therapy at a fixed frequency. The System operates by AC power and is used with 8 up to 12 faser modules, as standard 4 red and 4 infrared modules. The system consists of a Control Unit / Power Supply that houses the electronics and controls the power and varies the frequency of the each laser module. The weberneedle®basic laser and the weberneedle®basic "compact edition" laser are equipped with single fibre optics to bring the emitted energy to the tissue. That allows treatment either of small or of expanded pain areas as well as both at the same time.
VI. Summary of the Technical Characteristics of the weberneedle®basic laser as Related to the Referenced Predicate Devices.
The weberneedle@basic laser, the weberneedle@basic "compact edition" laser and the aforementioned predicate devices are infrared lamps as defined in 21CFR 890.5500. These devices utilize infrared and visible red diodes to generate topical heating for the purpose of elevating tissue temperatures for temporary relief of muscle and joint aches, pain and stiffness, minor arthritis pain or muscle spasm, the temporary increase in local circulation and the temporary relaxation of muscle. The weberneedle@basic laser, the weberneedle@basic "compact edition" laser and the named predicate devices have the same intended uses and similar technical and performance characteristics.
VII. Testing
Testing of the System includes functional performance testing and electrical safety testing.
VIII. Conclusions
Pursuant to the testing and comparison to the predicate devices, the weberneedle@basic laser and the weberneedle@basic "compact edition" laser has the same intended uses, with similar functional and performance characteristics. The weberneedle®basic laser and the weberneedle®basic "compact edition" laser are designed to comply with the generally accepted therapeutic heat performance specifications by producing a level of tissue
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pg 3 of 3
Weber Medical GmbH, Germany weberneedle@basic laser, 510(k) Notification June 19", 2008
36797 Lauenförde
temperature reported in literature and accepted by Federal Food and-Drug Administration.
The weberneedle®basic laser and the weberneedle®basic "compact edition" laser perform as intended and do not raise any new safety or efficacy issues. Submitter: Dr. med. Dipl. Chem. Michael Weber (Chairman & General Manager) Sohnreystrasse 6
weber medical GmbH · HRB 101161 HQL · Registergericht Holzminden
Bankverbindung: Commerzbank Holzminden · BLZ: 272 400 04 · Kontonummer: 58 00 610
Page 8 of 80
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with a double-stranded snake entwined around a staff. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Weber Medical GmbH % Underwriters Laboratories, Inc. Mr. Jeff D. Rongero 12 Laboratory Drive Research Triangle, North Carolina 27709
AUG 11 2008
Re: K073352 Trade/Device Name: weberneedle®basic laser weberneedle®basic "compact edition" laser Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: ILY Dated: July 28, 2008 Received: July 29, 2008
Dear Mr. Rongero:
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
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Page 2 - Mr. Jeff D. Rongero
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.
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Pretmarket, Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark N. Millerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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pg 1 of 1
Weber Medical GmbH, Germany weberneedle@basic laser, 510(k) Notification June 19", 2008
4. STATEMENT OF INDICATION FOR USE
510(k) Number (if known)
Pending
Device Name:
weberneedle@basic laser weberneedle@basic "compact edition" laser
Indication for Use:
The weberneedle@basic laser is indicated to provide topical heating for the following:
- · temporary increase of local blood circulation.
- · temporary relief of minor muscle and joint aches, pains, and stiffness.
- · temporary relaxation of muscles.
- · temporary relief of muscle spasms.
- · temporary relief of minor pain and stiffness associated with arthritis.
Prescription Use: X (Part 21 CFR 801 Subpart D) And/Or Over the Counter Use: . (21 CFR 807 Subpart C)
(Please do not write below this line - continue on another page if needed!)
D
(Divisio Division of General, I Restorative. and Neurological Devices
510(k) Number 1601332
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