LASERPEN PRACTISE AND EXPERT, HANDYLASER SPRINT, HANDYLASER TRION, PHYSIOLASER OLYMPIC, POLYLASER

K091675 · Reimers and Janssen GmbH · ILY · Dec 15, 2009 · Physical Medicine

Device Facts

• Record ID: K091675
• Device Name: LASERPEN PRACTISE AND EXPERT, HANDYLASER SPRINT, HANDYLASER TRION, PHYSIOLASER OLYMPIC, POLYLASER
• Applicant: Reimers and Janssen GmbH
• Product Code: ILY · Physical Medicine
• Decision Date: Dec 15, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The RJ Low Level Laser are intended to emit energy in the infrared spectrum to provide topical heating for the purposes of elevating tissue temperature when heat is indicated for the temporary relief of minor muscle and joint pain and stiffness, for the temporary relief of minor joint pain associated with arthrilis, to temporarily increase local blood circulation where applied and the relaxation of muscles. This is a prescription only device.

Device Story

RJ Low Level Laser family (LaserPen Expert, Handylaser Sprint, Handylaser Trion, Physiolaser Olympic, Polylaser) emits infrared energy to provide topical heating. Device operates by delivering low-level laser energy to target tissue; elevates tissue temperature to induce physiological effects including muscle relaxation and increased local blood circulation. Used by clinicians in professional settings to treat minor muscle/joint pain and stiffness, and arthritis-related pain. Output is thermal energy; healthcare provider applies device to patient skin surface. Benefits include non-invasive pain management and improved local circulation.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use consistent with the infrared lamp classification.

Technological Characteristics

Infrared laser-based heating device. Class II, Product Code ILY. Operates as an infrared lamp per 21 CFR 890.5500. Emits energy in the infrared spectrum for topical heating. Form factor varies by model (pen, handheld, multi-laser units).

Indications for Use

Indicated for patients requiring topical heating for temporary relief of minor muscle and joint pain/stiffness, minor joint pain associated with arthritis, temporary increase in local blood circulation, and muscle relaxation. Prescription use only.

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 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

AUG 2 6 2010

Reimers & Janssen GmbH % Mr. Werner Reimers Frohnacker 8 79297 Winden, Germany

Re: K091675

Trade/Device Name: LaserPen® Expert; Handylaser Sprint; Handylaser Trion; Physiolaser Olympic: Polylaser Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: Class II Product Code: ILY Dated: December 04, 2009 Received: December 12, 2009

Dear Mr. Reimers:

This letter corrects our substantially equivalent letter of December 15, 2009.

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. Iisting 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

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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. 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 Postmarket Surveillance at [phone]. For questions regarding 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 vours.

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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9. INDICATIONS FOR USE FORM (TEXT VERSION)

Indications for Use

510(k) Number (if known): K091675

Device Name: RJ Low Level Laser Family

Indications for Use:

The RJ Low Level Laser are intended to emit energy in the infrared spectrum to provide topical heating for the purposes of elevating tissue temperature when heat is indicated for the temporary relief of minor muscle and joint pain and stiffness, for the temporary relief of minor joint pain associated with arthrilis, to temporarily increase local blood circulation where applied and the relaxation of muscles. This is a prescription only device.

Prescription Use _x (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Michael P. O'Shea for mxm

isinn Siun-Division of Surgical. Orthopedic. and Residentive Devices

510(k) Number K091675