SCITON IMAGE HAIR REMOVAL LASER

K012552 · Sciton, Inc · GEX · Nov 5, 2001 · General, Plastic Surgery

Device Facts

• Record ID: K012552
• Device Name: SCITON IMAGE HAIR REMOVAL LASER
• Applicant: Sciton, Inc
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Nov 5, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Sciton, Inc. Image Hair Removal Laser is intended for use in surgical and aesthetic applications requiring selective photothermolysis of target chromophores in soft tissue in general and plastic surgery and dermatology. In addition it is intended to effect stable long term, or permanent hair reduction through selective targeting of melanin in hair follicles (where permanent hair reduction is defined as a long term stable reduction in the number of hairs growing after a treatment regimen)

Device Story

The Sciton Image Hair Removal Laser is a long-pulsed, solid-state infrared laser system (1064nm). It consists of a console, internal computer, control panel, articulated arm, footswitch, scanner, and cooling-capable handpieces. Operated by clinicians in surgical/dermatological settings, the device delivers laser energy to target melanin in hair follicles via selective photothermolysis. The system uses an internal computer to manage treatment parameters, including pulse duration and fluence. By heating target chromophores, the device achieves stable long-term or permanent hair reduction. The clinician monitors the procedure via the control panel and display, adjusting parameters to ensure effective treatment while utilizing integrated cooling to protect surrounding tissue.

Clinical Evidence

Bench testing only.

Technological Characteristics

Long-pulsed, solid-state infrared laser; 1064nm wavelength. System includes console, internal computer, articulated arm, footswitch, and cooling-capable handpieces. Operates via selective photothermolysis.

Indications for Use

Indicated for patients requiring selective photothermolysis of target chromophores in soft tissue for general, plastic surgery, and dermatology applications, and for stable long-term or permanent hair reduction via melanin targeting in hair follicles.

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

• Altus Medical, Nd:YAG Aesthetic Laser
• Laserscope, Long Pulse Nd:YAG

Submission Summary (Full Text)

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## NOV 0 5 2001

## 510K Summary Statement for the Sciton Inc Image Hair Removal Laser

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- 1. General Information
Submitter:

Sciton Inc 845 Commercial Street Palo Alto, CA 94303

Contact Person

Peter Allen

Summary Preparation Date

August 7, 2001

- 2. Names
Device Names

| Device Names | Image, Image Hair Removal Laser<br>and Image Long Pulse Nd:YAG |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| Primary Classification Names: | Laser Powered Surgical Instrument<br>for use in General, Plastic Surgery<br>and Dermatolgy in accordance with<br>21CFR 878-4810.79-GEX |

- 3. Predicated Devices
The product specifications, functionality, indications and for use, treatment parameters of the Sciton Inc Hair Removal Laser are the same or very similar to the following legally market lasers:

Altus Medical, Nd:YAG Aesthetic Laser

Laserscope, Long Pulse Nd:YAG

510K Image Hair Removal Laser Sciton Inc

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## 4. Product Description

The Sciton Inc, Hair Removal Laser is a long pulsed, solid state infrared laser. It is intended to deliver laser energy for use in surgical and aesthetic applications requiring the of Removal of Hair folicles. The Hair Removal Laser produces a beam of infrared light at a wavelength of 1064nm. The system consists of:

A laser console Internal computer Control panel and display Articulated Arm Footswitch with optional handswitch Scanner and Handpieces with cooling capability

- 5. Indications for Use
The Sciton, Inc. Image Hair Removal Laser is intended for use in surgical and aesthetic applications requiring selective photothermolysis of target chromophores in soft tissue in general and plastic surgery and dermatology. In addition it is intended to effect stable long term, or permanent hair reduction through selective targeting of melanin in hair follicles (where permanent hair reduction is defined as a long term stable reduction in the number of hairs growing after a treatment regimen)

- 6. Rationale for Substantial Equivalence
The Sciton Inc Hair Removal Laser shares the same indications for use, similar design features (including wavelength, active medium, cooling system and controls), similar functional features (including pulse duration and fluence), and similar treatment parameters of other marketed long pulse Nd:YAG laser systems (as opposed to Q-switched lasers). Therfore the Sciton Inc Hair Removal Laser is substantially equivalent to the Altus Medical Laser Nd:YAG Aesthetic Laser , Laserscope

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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three lines that resemble an abstract bird.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 0 5 2001

Mr. Peter Allen Director, Regulatory Affairs Sciton, Inc. 845 Commercial Street Palo Alto, California 94303

Re: K012552

Trade/Device Name: Sciton Image Hair Removal System Regulation Number: 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 7, 2001 Received: August 8, 2001

Dear Mr. Allen:

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. Peter Allen

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), 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.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Susan Walk, us

Image /page/3/Picture/5 description: The image contains a handwritten symbol or character. It appears to be a cursive letter, possibly a 'P' or a similar glyph, with a loop at the top and a curved line extending from the bottom. The stroke is thick and dark, suggesting it was written with a pen or marker.

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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NOV 0 5 2001

FDA Submission Cover Sheet

K012552

:

510(K) Number (if known):

0125 S2

Device Name:

Sciton Image Hair Removal Laser

Indications for Use:

The Sciton, Inc. Image Hair Removal Laser is intended for use in surgical and applications requiring selective photothermolysis of of target aesthetic aesthelic applications - requiring - selectry surgery and dermatology. In addition it is intended to effect stable long permanent hair requection through selective targeting of melanin in hair follies (where permanent hair through selective largeting of meaning in the number of hairs growing after a treatment regimen) ్ట్స్ బం

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| | Concurrence of CDRH, Office of Device Evaluation (ODE) |
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| Prescription Use | |
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OR

| | Over The Counter Use (Per 21CFR 801) |
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| | (Division Sign-Off) |
|---------------|-----------------------------------------------------------|
| | Division of General, Restorative and Neurological Devices |
| 510(k) Number | K012552 |

Section A-1 (Rev A 8-7-01)