AXIOM BIOLASER LLLT SERIES-1

K030622 · Axiom Usa., Inc. · NHN · Sep 9, 2003 · Physical Medicine

Device Facts

• Record ID: K030622
• Device Name: AXIOM BIOLASER LLLT SERIES-1
• Applicant: Axiom Usa., Inc.
• Product Code: NHN · Physical Medicine
• Decision Date: Sep 9, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Axiom BioLaser LLLT Series-1 is for adjunctive use in providing temporary relief of minor chronic Neck and shoulder pain of musculoskeletal origins.

Device Story

Axiom BioLaser LLLT Series-1 is a single diode laser device. It emits laser energy at 660 nm wavelength with a maximum output power of 5 mW. The device is intended for adjunctive use to provide temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin. It functions as a non-heating lamp for pain therapy. The device is operated by healthcare professionals in a clinical setting to deliver low-level laser therapy to the affected area. The therapeutic effect is achieved through the application of laser energy to the skin, which is intended to alleviate pain symptoms.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technical comparison to the predicate device.

Technological Characteristics

Single diode laser; 660 nm wavelength; maximum output power 5 mW; non-heating lamp for pain therapy; regulatory class II; product code NHN.

Indications for Use

Indicated for patients experiencing minor chronic neck and shoulder pain of musculoskeletal origin.

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

• Erchonia PL2000

Submission Summary (Full Text)

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## 510 (K) Summary

| Device Classification Name | Lamp, Non-heating for<br>Adjunctive use in pain therapy |
|----------------------------|----------------------------------------------------------------------|
| Regulation Number | 890.5500 |
| 510(k) Number | K030622 |
| Device Name | The Axiom BioLaser LLT Series - 1 |
| Applicant | Axiom Worldwide<br>9423 Corporate Lake Drive<br>Tampa, Florida 33634 |
| Contact | James J. Gibson |
| Product Code | NHN |

The Axiom Bio Laser LLT Series - 1 is a single diode laser which produces an Output power of no more than 5 mW of energy with a 660 nm wavelength. The Axiom BioLaser LLT Series - 1 is substantially equivalent to the Erchonia PL2000 with an output power of no more than 5 mW and with a 635 nm wavelength. The wavelength although they differ, do not substantially effect the Transmission through the skin. The technical aspects of both devices are Significantly equivalent, therefore, achieving the same treatment For the intended use of providing temporary relief of minor chronic neck And shoulder pain of musculoskeletal origins.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of three abstract human profiles facing right, with three parallel lines above them. The lines and profiles are black, and the background is white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 9 2003

Mr. James J. Gibson President Axiom Worldwide 9423 Corporate Lake Drive Tampa, Florida 33634

Re: K030622

Trade/Device Name: Axiom BioLaser LLLT Series-1 Regulation Number: 21 CFR 890.5500 Regulation Name: Lamp, Non-heating for adjunctive use in pain therapy Regulatory Class: II Product Code: NHN Dated: June 10, 2003 Received: June 11, 2003

Dear Mr. Gibson:

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. James J. Gibson

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

for 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): 长0 3 06 22

Device Name: Axiom BioLaser LLLT Series-1

Indications For Use:

Intended Use

The Axiom BioLaser LLLT Series-1 is for adjunctive use in providing temporary relief of minor chronic Neck and shoulder pain of musculoskeletal origins.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use _______

Muriam C. Provost

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

510(k) Number Ka030622