PROFILE 1320 LASER SYSTEM

K032459 · Sciton, Inc · GEX · Mar 9, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K032459
• Device Name: PROFILE 1320 LASER SYSTEM
• Applicant: Sciton, Inc
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Mar 9, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Sciton, Inc. Profile 1320 Laser is intended for use in general surgery and dermatology for the incision, excision, ablation, vaporization, coagulation, with hemostasis of soft tissue. It is indicated for the treatment of fine lines and wrinkles. It is also indicated for the treatment of back acne and atrophic acne scars.

Device Story

Profile 1320 Laser System is an Nd:YAG laser (1320 nm wavelength) for dermatological and surgical soft tissue procedures. System comprises laser console, internal computer, control panel, display, articulated arm, handpiece/scanner with cooling, and footswitch. Operated by clinicians in clinical settings. Laser energy delivered to target tissue to achieve incision, excision, ablation, vaporization, or coagulation. Cooling mechanism integrated into handpiece/scanner to manage thermal effects on skin. Output controlled by physician via console interface; clinical decision-making based on visual assessment of skin condition (wrinkles, acne, scars). Benefits include precise tissue interaction for cosmetic and dermatological improvements.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and comparison to legally marketed predicate devices.

Technological Characteristics

Nd:YAG laser system; 1320 nm wavelength. Features articulated arm delivery, handpiece/scanner with integrated cooling, internal computer control, and footswitch. Class II laser surgical instrument.

Indications for Use

Indicated for patients requiring soft tissue incision, excision, ablation, vaporization, or coagulation with hemostasis. Also indicated for treatment of fine lines, wrinkles, back acne, and atrophic acne scars.

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

• Profile 1320 Laser System (K022466, K022381)
• CoolTouch Nd:YAG Laser System (K031184, K030453, K022817, K014035, K012982)
• Candela Smoothbeam Laser System (K022884, K014128, K013825)

Submission Summary (Full Text)

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K032459

## Attachment IV

# 510(k) Summary

| Submitter: | Sciton, Inc. |
|----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 845 Commercial Street, Palo Alto, CA 94303 |
| Phone: | [phone] |
| Fax : | [phone] |
| Contact Person: | Jay M. Patel, Director of Regulatory Affairs |
| Date Prepared: | August 1, 2003 |
| Device Trade Name: | Profile 1320 Laser System |
| Common Name: | Nd:YAG Laser System |
| Classification Name: | Laser Surgical Instrument, 21 CFR 878.4810. |
| Legally Marketed<br>Predicate Device: | Profile 1320 Laser System (K022466, K022381)<br>CoolTouch Nd:YAG Laser System (K031184, K030453<br>K022817, K014035 and K012982)<br>Candela Smoothbeam Laser System (K022884, K014128<br>and K013825) |
| Description of<br>Profile 1320 Laser System: | Profile 1320 Laser System is an Nd:YAG laser producing<br>emission at a wavelength of 1320 nm. It consists of a laser<br>console, internal computer, control panel and displav. an<br>optical delivery system comprised of an articulated arm<br>and a handpiece or scanner with cooling capability, and a<br>footswitch. |
| Intended Use: | The Sciton, Inc. Profile 1320 Laser is intended for use in<br>general surgery and dermatology for the incision, excision,<br>ablation, vaporization, coagulation, with hemostasis of soft<br>tissue. It is indicated for the treatment of fine lines and<br>wrinkles. It is also indicated for the treatment of back acne<br>and atrophic acne scars. |
| Rationale for Substantial<br>Equivalence: | The Profile 1320 Laser System shares the same<br>indications for use, similar design features (including<br>wavelength, laser medium, power supply, cooling and<br>control system), functional features (including power<br>output, repetition rate, energy, spot size and fluence), and |
| | |
| | is therefore substantially equivalent to the above legally<br>marketed predicate devices. |
| Safety and Effectiveness<br>Information | The indications for use are based upon the indications for<br>use for predicate systems. Technologically, the Profile<br>1320 Laser System is substantially equivalent to the listed<br>predicate devices. Therefore, the risks and benefits for the<br>Profile 1320 Laser System are comparable to the predicate<br>devices. |
| Conclusion | The Profile 1320 shares similar indications for use, design<br>features, and similar functional features as, and therefore<br>is substantially equivalent to, the currently marketed<br>predicate devices. |

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MAR - 9 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Jay M. Patel Director of Regulatory Affairs Sciton, Inc. 845 Commercial Street Palo Alto, California 94303

Re: K032459 Trade/Device Name: Profile 1320 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 10, 2003 Received: December 12, 2003

Dear Mr. Patel:

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. Jay M. Patel

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,

Sincerely yours,

Mark N Milliman

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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### Attachment III

## Statement of Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: ___

Frofile 1320 Laser System

Indications for Use:

The Sciton, Inc. Profile 1320 Laser is intended for use in general surgery and dermatology for the incision, excision, ablation, vaporization, coagulation, with hemostasis of soft tissue.

It is indicated for the treatment of fine lines and wrinkles. It is also indicated for the treatment of back acne and atrophic acne scars.

(The indications for use in this paragraph are new per this 510k.)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21CFR801)

OR
Over-The-Counter Use

. Restoral ve. and Neurological Devices

510(k) Number K03245