WEBERNEEDLE BASIC LASER

K073352 · Weber Medical GmbH · ILY · Aug 11, 2008 · Physical Medicine

Device Facts

• Record ID: K073352
• Device Name: WEBERNEEDLE BASIC LASER
• Applicant: Weber Medical GmbH
• Product Code: ILY · Physical Medicine
• Decision Date: Aug 11, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

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.

Device Story

The weberneedle@basic laser and "compact edition" are non-invasive, portable therapeutic laser systems; deliver light energy to target tissue via red and infrared diodes. System comprises a control unit/power supply and 8 to 12 laser modules (standard 4 red, 4 infrared). Single fiber optics transmit emitted energy to tissue, allowing treatment of small or expanded pain areas. Operates on AC power; control unit manages electronics, power, and frequency of laser modules. Used by healthcare providers to provide continuous heat therapy. Output is topical heating; intended to increase local blood circulation, relax muscles, and relieve minor aches, pains, and stiffness associated with muscle spasms or arthritis.

Clinical Evidence

Bench testing only. Functional performance and electrical safety testing were conducted to verify compliance with therapeutic heat performance specifications.

Technological Characteristics

Non-invasive, portable therapeutic laser system. Utilizes red and infrared diodes for topical heating. Includes control unit/power supply and 8-12 fiber optic laser modules. Operates on AC power. Fixed frequency continuous heat therapy. No software algorithm described.

Indications for Use

Indicated for patients requiring topical heating for temporary relief of minor muscle/joint aches, pains, stiffness, muscle spasms, minor arthritis pain, and temporary increase in local blood circulation.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Thor Int. DDII Laser System (K033923)
• Chattanooga Group Vectra Genisys Laser System (K040662)

Submission Summary (Full Text)

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## AUG 11 2008

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Waber Medical GmbH Germany weberneedle@basic laser, 510(k) Notification June 1901. 2008

K073352

#### 5. 510(k) PREMARKET NOTIFICATION SUMMARY

(as per 21 CFR Part 807.92)

#### I. Applicant:

Weber Medical GmbH Sohnreystrasse 6 37697 Lauenförde GERMANY

Tel.: [phone] - 0 Fax: [phone] - 19 Email: [e-mail]

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

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Weber Medical GmbH. Germany weberneedle@basic laser, 510(k) Notification Juna 19 2008

K073352

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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Weber Medical GmbH, Germany weberneedle@basic laser, 510(k) Notification June 19", 2008

K073352

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

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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 [phone]. 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 [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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 [phone] or [phone] 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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Weber Medical GmbH, Germany weberneedle@basic laser, 510(k) Notification June 19", 2008

K073352

#### 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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