PROFILE 1320 LASER SYSTEM

K022466 · Sciton, Inc · GEX · Dec 31, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K022466
• Device Name: PROFILE 1320 LASER SYSTEM
• Applicant: Sciton, Inc
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Dec 31, 2002
• 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 also indicated for the treatment of periorbital and perioral wrinkles.

Device Story

Profile 1320 Laser System is an Nd:YAG laser emitting 1320 nm wavelength light. Device components include laser console, internal computer, control panel/display, articulated arm, handpiece or scanner with cooling capability, and footswitch. Operated by clinicians in surgical or dermatological settings. Laser energy is delivered to soft tissue to perform incision, excision, ablation, vaporization, coagulation, and hemostasis; also used for wrinkle treatment. Cooling mechanism integrated into handpiece/scanner protects tissue during procedure. Output allows precise tissue interaction for surgical and aesthetic applications.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use compared to the predicate device.

Technological Characteristics

Nd:YAG laser system; 1320 nm wavelength emission. Includes laser console, internal computer, articulated arm, handpiece/scanner with cooling, and footswitch. Class II device (21 CFR 878.4810).

Indications for Use

Indicated for patients requiring soft tissue incision, excision, ablation, vaporization, coagulation, and hemostasis in general surgery and dermatology, and for the treatment of periorbital and perioral wrinkles.

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

• CoolTouch Nd:YAG Laser System (K003715 and K014035)

Submission Summary (Full Text)

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022 466

SCITON

DEC 3 1 2002

# 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: | July 23, 2002 |
| 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: | CoolTouch Nd:YAG Laser System (K003715 and<br>K014035) |
| 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 display, 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 also indicated for the treatment of periorbital<br>and perioral wrinkles. |

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/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 feathers. 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

DEC 31 2002

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

Rc: K022466

Trade/Device Name: Profile 1320 Laser System Regulation Number: 878.4810 Regulation Name: Laser surgical instrument Regulatory Class: Class II Product Code: GEX Dated: October 30, 2002 Received: November 1, 2002

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 docs 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

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Page 2 - Mr. Jay M. Patel .

the quality systems (OS) 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]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

Muriam C. Purret

for 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 Us

K022466 510(k) Number (if known):

Profile 1320 Laser System Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

The Profile 1320 Laser System is intended for use in general surgery and dermatology for the incision, excision, ablation, vaporization, coagulation and hemostasis of soft tissue. It is also indicated for the treatment of periorbital and perioral wrinkles.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use<br>(Per 21CFR801) | <div style="display:flex; align-items:center;"><img alt="Tick" height="20" src="tick.png" width="20"/></div> |
|------------------------------------|--------------------------------------------------------------------------------------------------------------|
| OR | Over-The-Counter Use |

Miriam C. Provost

(Division Sign-Off)

Division of General, Restorative
and Neurological Devices

K022466