HILT FAMILY LASER: HILT I, HILT II, HILT III

K051537 · Cynosure, Inc. · ILY · Sep 26, 2005 · Physical Medicine

Device Facts

• Record ID: K051537
• Device Name: HILT FAMILY LASER: HILT I, HILT II, HILT III
• Applicant: Cynosure, Inc.
• Product Code: ILY · Physical Medicine
• Decision Date: Sep 26, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The HILT Family Laser is intended to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of muscle and joint pain and stiffness, arthritis pain, or muscle spasm, the temporary increase in local blood circulation and/or promoting relaxation of muscle.

Device Story

HILT Family Laser (HILT I, II, III) is an Nd:YAG infrared lamp system emitting 1,064 nm wavelength for heat therapy. Device delivers energy via contact or non-contact handpieces connected by 600 µm fiber optic cable. Non-contact handpiece uses spacer between output window and patient skin. System operates at 230 VAC; provides up to 10 Watts power. Pulse widths range 60-150 µs; repetition rates 10-40 Hz. Used by clinicians to elevate tissue temperature, providing temporary relief of muscle/joint pain, stiffness, arthritis, or muscle spasm, and to increase local blood circulation and promote muscle relaxation.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Nd:YAG laser; 1064 nm wavelength; 10W max power; 60-150 µs pulse width; 10-40 Hz repetition rate. Delivery via 600 µm fiber optic cable. Configurations: HILT I (non-contact), HILT II (non-contact), HILT III (contact and non-contact). Electrical: 230 VAC, 15A, 50-60 Hz.

Indications for Use

Indicated for patients requiring topical heating for temporary relief of muscle and joint pain, stiffness, arthritis pain, or muscle spasm; temporary increase in local blood circulation; and promotion of muscle relaxation.

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

• MLT-1000 IR Laser System

Submission Summary (Full Text)

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# SEP 2 6 2005

# 510(K) Summary

| | SEP 26 2005 | K051537<br>p. 1 of 1 |
|----------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| Submitter: | 510(K) Summary<br>El En<br>Via Baldanzese, 17-50041 | |
| Contact:<br>Date Summary Prepared:<br>Device Trade Name: | Calenzano (Florence), Italy<br>Andrea Tozzi<br>Director, Quality Assurance<br>June 9, 2005<br>HILT Family Laser | |
| Common Name: | Nd:YAG laser | |
| Classification Name: | Infrared Lamp<br>21 CFR 890.5500 | |
| Equivalent Device: | MLT-1000 IR Laser System | |
| Device Description: | The HILT Family Laser provides 1,064 nm wavelength. Laser<br>emission activation is by used selectable controller. Electrical<br>requirement is 230 VAC, 15A, 50-60 Hz, single phase. | |
| Intended Use: | The HILT Family Laser is intended to provide topical heating for the<br>purpose of elevating tissue temperature for temporary relief of muscle<br>and joint pain and stiffness, arthritis pain, or muscle spasm, the<br>temporary increase in local blood circulation and/or promoting | |
| Comparison: | relaxation of muscle.<br>The HILT Family Laser has the same indications for use, the same<br>principle of operation, and similar performance specifications as the<br>predicate devices. | |
| Nonclinical Performance Data: | none | |
| Clinical Performance Data: | none | |
| Conclusion:<br>Additional Information: | The HILT Family Laser is a safe and effective device for the<br>indications specified.<br>none | |

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Name of Manufacturer: El En SpA (Italy), represented by Cynosure, Inc.

Laser Model Name and Number: HILT Family Laser: HILT I, HILT II, HILT III; Nd: YAG laser, Infrared Lamp System.

Laser Type: (Circle all that apply) Luser Type: \ < Short CO2, Copper-Vapor, Diode, Dye, Nd: YAG, Erbium, Hol: YAG, Krypton, Ruby, KTP/532, Excimer, HENE, Accessory, Other _______________________________________________________________________________________________________________________________

Indications in this application: To provide topical heating for the purpose of elevating thateauous in this upplicamporary relief of muscle & joint pain & stiffness, arthritis pain or muscle spasm; the temporary increase in local blood circulation &/or promoting relaxation of muscle.

## FDA Document Control Number: K051537/S001

FDA Product Code: 90 ILY

#### Reviewer Computer Initials: ABC

#### Date of Clearance Letter: 9/16/05

Basis of Approval: (Circle all that apply) Predicate Device (PD) Clinical Data (CD), Animal Data (AD), Specifications (SPECS), Bench Test Data (BTD), Historical Information (HI), Other __________________________________________________________________________________________________________________________

Description of Laser: The Hilt Family Laser: HILT I, HILT III is a Nd:YAG laser, Intrared Lamp system for heat therapy. The three possible treatment configurations are initalou Eamp Hilt II, non-contact; Hilt III, both contact and non-contact. The noncontact hand piece utilizes a spacer between the output window and the skin of the patient.

Operation Modes: (Circle all that apply) CW, Pulsed O-Switched, Mode Locked, Contact, Free Beam, Other ________________________________________________________________________________________________________________

CW, Pulsed, Q-Switched, Mode Locked, Contact, Free Beam, Other:***_***_

Wavelength in Nanometers: 1064 nm

Power/Energy Range (Watts): 10 Maximum

Pulse Width: Hilt I, 60-150 μs; Hilt II, 80-120 μs; Hilt III, 60-100 μs

Repetition Rate: Hilt I, 10-30 Hz; Hilt II, 10-40 Hz; Hilt III, 10-30 Hz

Delivery System: Contact and Non-contact hand pieces connected to the system via a 600 µm diameter fiber optic cable.

Comments:

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" are arranged in a circular pattern around the caduceus.

Public Health Service

SEP 26 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. George Cho Sr. Vice President Medical Technology Cynosure, Inc. 10 Elizabeth Drive Chelmsford, Massachusetts 01824

Re: K051537

Trade/Device Name: El En HILT Family Laser (HILT I, HILT II, HILT III) Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: ILY Dated: August 19, 2005 Received: August 22, 2005

Dear Mr. Cho:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have teviewed your becament to (2) the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrobare) to regary the Medical Device Amendments, or to conninered province with the provisions with the provisions of the Federal Food. Drug, de vices that have been recuire approval of a premarket approval application (PMA). and Cosmetic recry that ac nevice, subject to the general controls provisions of the Act. The r ou may, dicrerero, market alle a Act include requirements for annual registration, listing of general controls provisions of the tice, 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 If your device is elabilitional controls. Existing major regulations affecting your device can may be subject to back acated 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 i lease oc advisou that i Dr o lessian that your device complies with other requirements of the Act that I Dri has made a and regulations administered by other Federal agencies. You must or any I outhal 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 Of N Fart 007); idocinig (2 (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. George Cho

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin manies.org your device of your device to a legally prematice notification: "The PDF intelling sification 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 If you desire specific advice for your as [phone]. Also, please note the regulation entitled, Comation of Critics of Course to premarket notification" (21CFR Part 807.97). You may obtain Misoranding of reference to premaintentibilities under the Act from the Division of Small other general information on your respenses Assistance at its toll-free number [phone] or Manufacturers, International and Soless http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Barbara Buchholz
for

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K051537 510(k) Number (if known):

### Device Name: __ El En HILT Family Laser (HILT I, HILT II, HILT III)

Indications For Use:

The HILT Family Laser is intended to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of muscle and joint pain and stiffness, arthritis pain, or muscle spasm, the temporary increase in local blood circulation and/or promoting relaxation of muscle.

> Prescriptive Use X OR (Part 21 CFR 801 Subpart D)

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Barbara BonettD for MKM

Division of General, Restorative. and Neurological Devices

**510(k) Number** K051537