RELIANT LASER SYSTEM II

K040617 · Reliant Technologies, Inc. · GEX · Jun 15, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K040617
• Device Name: RELIANT LASER SYSTEM II
• Applicant: Reliant Technologies, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jun 15, 2004
• 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: 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.

Device Story

Reliant Laser System II utilizes fiber lasers and focusing optics to deliver energy patterns to skin and upper dermis; intended for dermatological soft tissue coagulation, wrinkle treatment, and pigmented lesion photocoagulation. System includes embedded processor for control. Operated by clinicians in dermatological settings. Output consists of controlled laser energy; clinical benefit includes tissue coagulation and lesion reduction. Device functions via photocoagulation principle.

Clinical Evidence

Clinical evaluations conducted to demonstrate device performance for intended dermatological indications. Data gathered from clinical studies confirm the device functions as intended without introducing new safety or effectiveness concerns.

Technological Characteristics

Fiber laser system with focusing optics; embedded processor control. Conforms to 21 CFR Laser Performance Standard. Class II device (21 CFR 878.4810).

Indications for Use

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

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 (K031795)
• Altus Medical CoolGuide Lasers w/Pulse Light Handpiece (K023954)
• Aramis II Dermatological Laser (K023734)
• Candela Smoothbeam Laser System (K030846)
• Candela YAG Family of Lasers (K033172)
• Lumenis Ultrapulse Encore Laser (K022060)

Submission Summary (Full Text)

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K040617 1 of 2

### Reliant Technologies, Inc. Reliant Laser System II 510(k) Premarket Notification

## 510(k) SUMMARY

As required by Section 12 of the Medical Devices Act of 1990, Reliant technologies, Inc.
Continent of the Medical Conciler overlies arealished for Relight As required by Section 12 of the Medical Do reess information available for Reliant
is providing a summary of safety and effectiveness information available for Reliant is providing a summaly of surces and errost Announce substantial equivalence decision making process.

| Submitter: | Reliant Technologies, Inc. |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 260 Sheridan Ave.<br>Suite 309<br>Palo Alto, CA 94306 |
| Contact Person: | Heather Tanner<br>Clinical and Regulatory Affairs |
| Telephone: | [phone] ext. 103 |
| Facsimile: | [phone] |
| Date prepared: | March 5, 2004 |
| Device Trade Name: | Reliant Laser System II |
| Common Name: | Dermatology Laser |
| Classification Name: | Laser Surgical Instrument<br>21 C.F.R § 878.4810 |
| Legally Marketed Predicate Devices: | -Reliant Laser System K031795<br>-Altus Medical CoolGuide Lasers w/Pulse<br>Light Handpiece K023954<br>-Aramis II Dermatological Laser K023734<br>-Candela Smoothbeam Laser System<br>K030846<br>-Candela YAG Family of Lasers<br>K033172<br>-Lumenis Ultrapulse Encore Laser,<br>K022060 |

## Description of the Reliant Laser System II:

The Reliant Laser System II consists of a set of fiber lasers, controlled by an embedded The Reliant Laser System if consists of a set of the estanting and focusing optics processor, to be used in demiatores). The issores and upper dermis. Device to defiver a pattern of enttachments and pre-treatment solution.

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KC40617 2082

## Indications for use of Reliant Laser System II:

The Reliant Laser System II is intended for:

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.

#### Performance Standards:

As a laser product, the Reliant Laser System II is required to conform and does conform to the Laser Performance Standard (21 CFR).

# SUBSTANTIAL EQUIVALENCE COMPARISON

The technological characteristics and indications for use of the Reliant Laser System II The technological characteristics addicate laser devices. These devices are equivalent in are simmal to those of the entra product specification, and product specifications. Any terms of design, materials, principal on open II and the predicate devices do not raise new issues regarding safety or effectiveness.

#### Clinical Performance Data

Results of clinical evaluations were used to demonstrate that the Reliant Technologies Results of Childed everalations were ally intended. Sufficient data have been gathered Laser System II functioned as onlinear. Anteneral
from clinical studies to determine that the Reliant Laser System II performs as clinically iron ennied stadies to avissues of safety and effectiveness are introduced.

#### CONCLUSION

Based on the design, materials, function, intended use, and clinical evaluation, the Reliant Dased on the design, materially equivalent to the devices currently Technologies Laser Dystem II 18 July and Cosmetic Act. In addition, the Reliant marketed under the Federal Food, Brag and Catety or effectiveness issues. Therefore, rechnologics Luser by Sective as are reasonably assured, justifying 510(k) clearance for commercial sale.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol consisting of three curved lines that resemble a human figure.

Public Health Service

JUN 1 5 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K040617 Trade/Device Name: Reliant Laser System II 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: May 5, 2004 Received: May 6, 2004

Dear Ms. Tanner:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becamed 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 encreativent of the enactment date of the Medical Device Amendments, or to Conniner of May 20, 11:25 PM ] List accordance with the provisions of the Federal Food, DNA (A de vices that have been receasined require approval of a premarket approval application (PMA). and Cosmetic rear (110c) that to nevice, subject to the general controls provisions of the Act. The r ou may, diorelore, maints of the Act include requirements for annual registration, listing of gencral controls provisions of wactice, 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 classified (500 a0010) ins. Existing major regulations affecting your device can may be subject to suen additional controller in 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 Picase oe advised that I DA 3 issualles or our device complies with other requirements of the Act that IDA has made a determinations administered by other Federal agencies. You must of ally it cuchar statules and regaraments ancluding, but not limited to: registration and listing (21 Comply with an the Her 811 CFR Part 801); good manufacturing practice requirements as set CFR in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic 101111 the quality systems (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 begin maxing of substantial equivalence of your device to a legally premarket notification. The PDA miding of backand 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 ac 110 cm. Also, please note the regulation entitled, and contact the Office of Complanes at (so t notification" (21CFR Part 807.97). You may obtain Misolanding by telefono to premaintentibilities under the Act from the Division of Small other gelleral informational and Consumer Assistance at its toll-free number [phone] or Manufacturers, International and Octess 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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# Indications for Use

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name: Reliant Technologies Laser System II

Indications For Use:

The Reliant Technologies Laser System II is intended for:

-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.

Prescription Use_ X (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 ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

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

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