RELIANT LASER II SYSTEM AND ACCESSORIES

K042319 · Reliant Technologies, Inc. · GEX · Mar 10, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K042319
• Device Name: RELIANT LASER II SYSTEM AND ACCESSORIES
• Applicant: Reliant Technologies, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Mar 10, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Reliant Laser System II is intended for use in: Dermatological procedures requiring the coagulation of soft tissue; Treatment of periorbital wrinkles; Photocoagulation of pigmented lesions, such as, but not limited to lentigos (age spots), solar lentigos (sun spots) and dyschromia; Skin resurfacing procedures.

Device Story

Reliant Laser System II (Fraxel SR Laser System) is a dermatological laser surgical instrument. It utilizes fiber lasers, controlled by an embedded processor, to deliver thermal energy to the epidermis and upper dermis. The system employs scanning and focusing optics to create a specific pattern of energy. Accessories include tip attachments and a pre-treatment solution. The device is operated by clinicians in a dermatological setting. The system is used to coagulate soft tissue, treat periorbital wrinkles, photocoagulate pigmented lesions, and perform skin resurfacing. The output is a controlled thermal effect on the skin, which the clinician uses to achieve desired aesthetic or therapeutic outcomes. The device benefits patients by providing a non-invasive or minimally invasive method for skin rejuvenation and lesion treatment.

Clinical Evidence

Clinical analysis was conducted on Non-Significant Risk and IDE Reliant studies to support the updated indications for use language. Data gathered confirmed the system performs as clinically intended and introduces no new safety or effectiveness concerns.

Technological Characteristics

Fiber laser system; controlled by embedded processor; uses scanning and focusing optics for thermal energy delivery. Includes tip attachments and pre-treatment solution. Class II device, product code GEX, regulation 878.4810.

Indications for Use

Indicated for dermatological procedures requiring soft tissue coagulation, treatment of periorbital wrinkles, photocoagulation of pigmented lesions (e.g., lentigos, dyschromia), and skin resurfacing.

Regulatory Classification

Identification

(1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.

Predicate Devices

• Reliant Laser System II (K040617)
• Reliant Laser System (K031795)
• Lumenis UltraPulse Encore Carbon Dioxide Surgical Laser and Delivery Device Accessories (K022060)

Submission Summary (Full Text)

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Reliant Technologies, Inc.

. ﻧﻮﻣﺒﺮ

1 | 3

Premarket Notification:

| K042319 | Reliant Laser II System and Accessories, Labeling Change |
|-------------|----------------------------------------------------------|
| MAR 10 2005 | |

1. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

REGULATORY AUTHORITY

Safe Medical Devices Act of 1990, 21 CFR 807.92

COMPANY NAME/CONTACT

| Heather Tanner | |
|----------------------------|--|
| Reliant Technologies, Inc. | |
| 260 Sheridan Ave. | |
| Palo Alto, CA 94306 | |
| 650 473-0200, 103 | |
| 650 473-0537 fax | |
| [e-mail] | |

NAME OF DEVICE

| Trade Name: | Reliant Laser II System and Accessories (Fraxel SR Laser System) |
|------------------------|------------------------------------------------------------------|
| Common Name: | Laser Surgical Instrument |
| Regulation Number | 878.4810 |
| Product code: | GEX |
| Device Panel: | General Surgery/Restorative Devices |
| Device Classification: | Class II |

PREDICATE DEVICES

| Name: Reliant Laser System II | |
|-----------------------------------------------------------------------------------------------|--|
| 510(k) #: K040617 | |
| Name: Reliant Laser System | |
| 510(k) #: K031795 | |
| Name: Lumenis UltraPulse Encore Carbon Dioxide Surgical Laser and Delivery Device Accessories | |
| 510(k) #: K022060 | |

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Reliant Technologies, Inc.

2/3 042319

### DEVICE DESCRIPTION

The Reliant Laser System II consists of a set of fiber lascrs, controlled by an embedded processor, to be used in dermatology. The laser system uses scanning and focusing optics to deliver a pattern of thermal cnergy to the cpidermis and upper dermis. Device accessories include tip attachments and pre-treatment solution.

#### INDICATION FOR USE STATEMENT

The Reliant Laser System II is intended for use in:

Dermatological procedures requiring the coagulation of soft tissue;

Treatment of periorbital wrinkles;

Photocoagulation of pigmented lesions, such as, but not limited to lentigos (age spots), solar lentigos (sun spots) and dyschromia;

Skin resurfacing procedures.

## SUBSTANTIAL EQUIVALENCE COMPARISON

#### Technological Characteristics

There has been no change to the Reliant Tcchnologics Laser System II. The system is identical to the Reliant Technologics 510(k)s cleared under 510(k) K031795 and K040617.

#### Indications for Use

Substantial equivalence for the Reliant Laser II System is supported by the predicate devices listed in this submission, which have identical or similar indication statements.

#### Clinical Performance Data

Clinical analysis was conducted on Non-Significant Risk and IDE Roliant studies to support the change in the language in the indications for use statement. Sufficient safety and efficacy data has been gathered to detenmine that the Roliant Lasor II \$ ystem performs as clinically intended and that no new issues of safety and effectiveness are ntroduced.

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Reliant Technologies, Inc. Coup J 319 3/3

Premarket Notification: Reliant Laser II System and Accessories, Labeling Change

## CONCLUSION

Based on the design, materials, function, intended use and clinical evaluation, the Reliant Based on the design, materials, Inneable, misalent to the devices currently Laso II System and Accessories IS Mostantially eqtic Act. Safety and effectiveness are marketed under the Foderal FOOG, 17ttig and Connect or being made in the laser reasonably assured, justifying >10(k) cicannee, rro onazged and clections performance data
or accessories. The technical, mechanical, performance, and cleared by this or accessories. The technical, mechanical, performatio, and unaffected by this change in labeling.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 0 2005

Ms. Heather Tanner Clinical Research/Regulatory Affairs Manager Reliant Technologies, Inc. 260 Sheridan Avenue, Suite 309 Palo Alto, California 94306

Re: K042319

R042317
Trade/Device Name: Reliant Laser System II and Accessories (Fraxel SR Laser System) 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: GEX Dated: December 7, 2004 Received: December 10. 2004

Dear Ms. Tanner:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt have reviewed your because roges for 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 encrosure) to regary the Medical Device Amendments, or to commerce pror to May 20, 11:37 | 11 accordance with the provisions of the Federal Food, DINE, de necs that here boon require approval of a premarket approval application (PMA). and Cosmetic Herefore, market the device, subject to the general controls provisions of the Act. The r ou may, therefore, mains of the Act include requirements for annual registration. Iisting of general controls provider in a practice, labeling, and prohibitions against misbranding and adultcration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it rr your de vice is one additional controls. Existing major regulations affecting your device can may oc subject to satin adallarian legulations. 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 r tease be advised that i Drivies and on over device complies with other requirements of the Act that 1197 has intact a and regulations administered by other Federal agencies. You must on any I 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 CI K Fat 6077, labeling (2 (QS) regulation (21 CFR Part 820); and if applicable, the clectronic forth in the quinn control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Heather Tanner

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to ocgin mankemig your antial equivalence of your device to a legally premarket nothication. The PDA midning of substantal. Popularian Por your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (1 CFR Part 80) ), please If you desire specific advice tor your ac not of the same of the regulation entitled. contact the Office of Compliance at (210) 216 - 101 (21CFR Part 807.97). You may obtain "Misbranding by relevence to premarket notifications in the Act from the Division of Snall other general information on your responsible in the live in the mumber (800) 638-204 or Manufacturers, International and Consulter Forse and Consectivindustry/support/index.html.

Sincerely yours,

sincerely yours,

Mark A. Wilkinson

Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

910(k) Number (if known): K042319

Device Name: Reliant Laser System II and Accessories (Fraxel SR Laser System)

Indications For Use:

"The Reliant Laser System II is intended for use in:

Dermatological procedures requiring the coagulation of soft tissue;

Treatment of periorbital wrinkles;

Photocoagulation of pigmented lesions, such as, but not limited to lentigos (age spots), solar lentigos (sun spots) and dyschromia;

Skin resurfacing procedures."

Prescription Use
(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 ANDTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

*mali A. Millheez*

(Division Sign-Off)

al, Restorative. and Neurological Devices

**510(k) Number** K042319