BIOPTRON PRO LIGHT THERAPY SYSTEM AND BIOPTRON COMPACT III LIGHT THERAPY SYSTEM

K032216 · Bioptron AG · NHN · Feb 4, 2004 · Physical Medicine

Device Facts

• Record ID: K032216
• Device Name: BIOPTRON PRO LIGHT THERAPY SYSTEM AND BIOPTRON COMPACT III LIGHT THERAPY SYSTEM
• Applicant: Bioptron AG
• Product Code: NHN · Physical Medicine
• Decision Date: Feb 4, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Bioptron Pro and Bioptron Compact III Light Therapy Systems is indicated for adjunctive use in providing temporary relief of is includied for dejaried shoulder pain of musculoskeletal origin.

Device Story

Bioptron Pro and Bioptron Compact III are light therapy systems; intended for adjunctive use in temporary relief of musculoskeletal shoulder pain. Devices emit light energy; mechanism involves non-heating light application to affected area. Operated by clinicians or patients in clinical or home settings. Output provides therapeutic light exposure; intended to alleviate pain symptoms. Benefit includes non-invasive pain management.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on technological characteristics and intended use.

Technological Characteristics

Non-heating light therapy system; classified under 21 CFR 890.5500. Device functions as a lamp for adjunctive pain therapy. No specific materials, energy specs, or software algorithms described.

Indications for Use

Indicated for patients experiencing shoulder pain of musculoskeletal origin requiring adjunctive therapy for temporary relief.

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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB - 4 2004

Bioptron AG c/o Mr. Kevin Walls Regulatory Insight, Inc. 13 Red Fox Lane Littleton, Colorado 80127

Re: K032216

Trade/Device Name: Bioptron Pro Light Therapy System Bioptron Compact III Light Therapy 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: October 27, 2003 Received: November 6, 2003

Dear Mr. Walls:

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 devretions 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 Foend, Or ug 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 aftecting your devive 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 detcrmination 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 (Scctions 531-542 of the Act); 21 CFR 100-1000.

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Page 2 - Mr. Kevin Walls

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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam 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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510(k) Number (if known): 《C3ススノ 6

- Bioptron Pro Light Therapy System Device Name: Bioptron Compact III Light Therapy System
- Indications for Use: The Bioptron Pro and Bioptron Compact III Light Therapy Systems is indicated for adjunctive use in providing temporary relief of is includied for dejaried shoulder pain of musculoskeletal origin.

PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of General, Restorative and Neurological Devices 510(k) Number__

Prescription Use X (Per 21 CFR 801.109)

Muriam C. Provost

neral. Restorative and Neurological Dev

KO322/6