RELIANT TECHNOLOGIES C300 CHILLER SYSTEM AND ACCESSORIES

K071621 · Reliant Technologies, Inc. · GEX · Oct 9, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K071621
• Device Name: RELIANT TECHNOLOGIES C300 CHILLER SYSTEM AND ACCESSORIES
• Applicant: Reliant Technologies, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Oct 9, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Reliant Technologies C300 Chiller System is intended for use in: Skin cooling in conjunction with drinatological laser treatments to reduce pain and thermal damage to skin tissue.

Device Story

C300 Chiller System is a thermoelectric cooler utilizing Peltier effect; employs solid-state heat pumps with no moving parts. Device housed in single console; connects to 110 VAC outlet. User operates via power switch and digital controller to select temperature; delivers low-temperature air through treatment tube. Used in clinical settings during laser procedures to provide skin cooling; reduces patient pain and thermal tissue damage.

Clinical Evidence

No clinical data provided. Safety and effectiveness determined through substantial equivalence to predicate devices and bench testing of cooling capacity.

Technological Characteristics

Thermoelectric cooler (TEC) utilizing Peltier effect; solid-state heat pumps; no moving parts. Single housing console; 110 VAC power source. Digital controller for temperature selection. Delivers low-temperature air via treatment tube.

Indications for Use

Indicated for skin cooling during dermatological laser treatments to reduce pain and thermal damage to skin tissue.

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

• Paradigm-Trex, LLC, DermaChiller 4 (K014253)
• MedArt Corporation, MedArt 520 Cooling System (K000503)

Submission Summary (Full Text)

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- 9 2007

OCT

# K071621

#### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

# REGULATORY AUTHORITY

Safe Medical Devices Act of 1990, 21 CFR 807.92

### COMPANY NAME/CONTACT

Dan Marinsik Reliant Technologies, Inc. 464 Ellis St. Mountain View, CA 94043 650 605-2237 650 605-2037 fax [e-mail]

# NAME OF DEVICE

Trade Name: Common Name: Regulation Number Product code: Device Panel: Device Classification:

Reliant Technologies C300 Chiller System Skin Refrigerant 878.4810 GEX General Surgery/Restorative Devices Class II

# LEGALLY MARKETED PREDICATE DEVICES

Name: Paradigm-Trex, LLC, DermaChiller 4 510(k) #: K014253

> Name: MedArt Corporation, MedArt 520 Cooling System 510(K) #: K000503

### DEVICE DESCRIPTION

The C300 Chiller System is a thermoelectric cooler (TECs) which utilizes the Peltier effect. The chiller employs solid-state heat pumps that cool thermoelectrically and contain no moving parts. The C300 Chiller System is contained within a single housing. The chiller console is electrically connected to a standard 110 VAC wall outlet. The unit delivers low temperature air at an adjustable rate through a treatment tube

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The user interacts with the C300 Chiller System by turning the power switch to the on position and selecting the desired temperature via the display on the digital controller

# INDICATION FOR USE STATEMENT

The Reliant Technologies C300 Chiller System is intended for use in:

Skin cooling in conjunction with drinatological laser treatments to reduce pain and thermal damage to skin tissue.

#### SUBSTANTIAL EQUIVALENCE COMPARISON

#### Indications for Use

Substantial equivalence for the Reliant Technologies C300 Chiller System and Accessories is supported by the predicate devices listed in this submission, which have identical or similar indication statements.

#### Clinical Performance Data

Sufficient safety data has been gathered to determine that the Reliant Technologies C300 Chiller System performs as clinically intended and that no new issues of safety and effectiveness are introduced.

### Technological Characteristics

Key technological characteristics of the Reliant Technologies C300 Chiller System, such as cooling capacity, are equivalent to the Paradigm-Trex, LLC, DermaChiller 4 as described in submission K014253 and the MedArt Corporation, MedArt 520 Cooling System as described in submission K000503.

### CONCLUSION

Based on the design, materials, function, intended use and clinical evaluation, the Reliant Technologies C300 Chiller System is substantially equivalent to the devices currently marketed under the Federal Food, Drug and Cosmetic Act. No changes are being made in the laser wavelength or operating principle. Safety and effectiveness are reasonably assured, justifying 510(k) clearance.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines forming its body and head. The symbol is enclosed within a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" in a sans-serif font. The text is arranged around the upper half of the circle, with the symbol positioned in the center.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT - 9 2007

Reliant Technologies, Inc. % Mr. Dan Marinsik Senior Director, Clinical Regulatory, & Quality 464 Ellis Street Mountain View, California 94043

Re: K071621

Trade/Device Name: Reliant Chiller 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: August 31, 2007 Received: September 05, 2007

Dear Mr. Marinsik:

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

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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 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/industry/support/index.html.

Sincerely yours,

Mark M. Mikkelsen

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

Enclosure

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cc: HFZ-401 DMC HFZ-404 510(k) Staff HFZ-410 DGRND/GSDB D.O. f/t:SPB:kxl:10-3-07

# OC Numbers:

| Division of Enforcement A | 240-276-0115 |
|-----------------------------------------------------------|--------------|
| Dental, ENT and Ophthalmic Devices Branch | 240-276-0115 |
| OB/GYN, Gastro. & Urology Devices Branch | 240-276-0115 |
| General Hospital Devices Branch | 240-276-0115 |
| General Surgery Devices Branch | 240-276-0115 |
| Division of Enforcement B | 240-276-0120 |
| Cardiovascular & Neurological Devices Branch | 240-276-0120 |
| Orthopedic, Physical Medicine & Anesthesiology Devices Br | 240-276-0120 |

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Reliant Technologies, Inc.

Premarket Notification: Reliant Chiller System and Accessories,

#### INDICATIONS FOR USE STATEMENT B.

510(k) Number: K071621

Device Name: Reliant Chiller System

Indications for Use:

The Reliant Chiller System is intended for use in:

Skin cooling in conjunction with dermatological laser treatments to reduce pain and thermal damage to skin tissue.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
or Over-The
(Per 21 CFR 801.109)

Over-The-Counter Use

Alinh N. Milhem

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

Confidential

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