PROFILE 1064 LASER SYSTEM

K023881 · Sciton, Inc · GEX · Jun 13, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K023881
• Device Name: PROFILE 1064 LASER SYSTEM
• Applicant: Sciton, Inc
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jun 13, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Profile 1064 Laser Systems and Accessories are intended for use in the medical specialties of general and plastic surgery, dermatology, endoscopic/laproscopic general surgery, gastroenterology, gynecology, otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, pulmonary/thoracic surgery and urology for surgical and aesthetic applications. Dermatology: Coagulation and hemostasis of benign vascular lesions such as, but not limited to port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg veins and spider veins. The lasers are also intended for the treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), café au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue/black tattoos) and plaques. Additionally, the lasers are indicated for pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments. Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. Removal of unwanted hair, for the stable long term, or permanent hair reduction through selective targeting of melanin in hair follicles, and for the treatment for pseudofolliculitis barbae (PFB). The Profile 1064 Laser Systems and Accessories are indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin. The Profile 1064 Laser Systems and Accessories are indicated for the treatment of facial wrinkles. The intended use of the contact cooling system in the Profile handpiece is to provide cooling of the skin prior to, during and after laser treatment, for the epidermal protection and reduction of pain during laser treatment, to allow for the use of higher fluences for laser treatments such as hair removal and vascular lesions, and to reduce the potential side effects of laser treatments. Surgical Applications: Incision/excision and cutting, ablation, coagulation/hemostasis of soft tissue in the performance of surgical applications in endoscopy/laparoscopy, gastroenterology, general surgery, head and neck/otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, plastic surgery, pulmonary/thoracic surgery, gynecology (e.g. menorrhagia) and urology.

Device Story

Profile 1064 Laser System is an Nd:YAG laser (1064nm) for surgical and aesthetic applications. System components: laser console, internal computer, control panel/display, articulated arm, handpiece/scanner with contact cooling, and footswitch. Operated by clinicians in clinical settings. Device delivers laser energy to target tissues for incision, excision, ablation, coagulation, or hemostasis. Contact cooling system provides epidermal protection and pain reduction, enabling higher fluences for hair removal and vascular treatments. Output is controlled by the clinician via the console and footswitch to achieve desired therapeutic effects on soft tissue or skin lesions.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and indications for use identical to previously cleared Sciton laser systems.

Technological Characteristics

Nd:YAG laser; 1064nm wavelength; articulated arm delivery; contact cooling system for epidermal protection; internal computer control; console-based system.

Indications for Use

Indicated for patients requiring surgical or aesthetic laser procedures across multiple specialties including dermatology, plastic surgery, and general surgery. Specific applications include vascular/pigmented lesion treatment, hair reduction (all Fitzpatrick skin types I-VI), scar reduction, and facial wrinkle treatment. Contraindications not specified.

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

• Sciton laser systems (K002853, K003046 & K010285)
• Altus Medical Aesthetic Nd:YAG Lasers (K991234, K991798, K003202, K014040, K022226)
• Lyra/Orion Laser Systems (Laserscope) (K990718, K990903, K003147, K003765, K010284, K010834, K020021)
• VeinLase (HGM) (K981952)

Submission Summary (Full Text)

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KO23881

# 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: | November 18, 2002 |
| Device Trade Name: | Profile 1064 Laser System |
| Common Name: | Nd:YAG Laser System |
| Classification Name: | Laser Surgical Instrument, 21 CFR 878.4810. |
| Legally Marketed<br>Predicate Device: | Sciton's laser systems (K002853, K003046 & K010285).<br>Altus Medical Aesthetic Nd:YAG Lasers (K991234,<br>K991798, K003202 and K014040 and K022226);<br>Lyra/Orion Laser Systems manufactured by Laserscope<br>(K990718, K990903, K003147, K003765, K010284,<br>K010834 and K020021);<br>and VeinLase, manufactured by HGM (K981952). |
| Description of<br>Profile Laser System: | Profile Laser System is an Nd:YAG laser producing<br>emission at a wavelength of 1064nm. 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 Profile 1064 Laser Systems and Accessories are<br>intended for use in the medical specialties of general and<br>plastic surgery, dermatology, endoscopic/laproscopic<br>general surgery, gastroenterology, gynecology,<br>otorhinolaryngology (ENT), neurosurgery, oculoplastics,<br>orthopedics, pulmonary/thoracic surgery and urology for<br>surgical and aesthetic applications. |

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### Dermatology:

Coagulation and hemostasis of benign vascular lesions such as, but not limited to port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg veins and spider veins. The lasers are also intended for the treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), café au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue/black tattoos) and plaques. Additionally, the lasers are indicated for pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.

Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.

Removal of unwanted hair, for the stable long term, or permanent hair reduction through selective targeting of melanin in hair follicles, and for the treatment for pseudofolliculitis barbae (PFB). The Profile 1064 Laser Systems and Accessories are indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin.

The Profile 1064 Laser Systems and Accessories are indicated for the treatment of facial wrinkles.

The intended use of the contact cooling system in the Profile handpiece is to provide cooling of the skin prior to. during and after laser treatment, for the epidermal protection and reduction of pain during laser treatment, to allow for the use of higher fluences for laser treatments such as hair removal and vascular lesions, and to reduce the potential side effects of laser treatments.

#### Surgical Applications:

Incision/excision and cutting, ablation, coagulation/hemostasis of soft tissue in the performance of surgical applications in endoscopy/laparoscopy, gastroenterology, general surgery, head and neck/otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, plastic surgery, pulmonary/thoracic surgery, gynecology (e.g. menorrhagia) and urology.

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| Rationale for Substantial<br>Equivalence: | The Profile Laser System and Accessories share the same<br>indications for use and technological characteristics and is<br>therefore substantially equivalent according to 510(k)<br>quidelines to the above legally marketed predicate<br>devices. |
|-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Safety and Effectiveness<br>Information: | The above indications for use are based upon the<br>indications for use for predicate laser systems.<br>The technological characteristics are identical to previous<br>predicate Sciton's laser systems (K002853, K003046 &<br>K010285). As a result, the risks and benefits are<br>comparable to the predicate devices.<br>We therefore conclude that there are no issues of safety or<br>effectiveness raised by the introduction of this device. |

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines forming its body and head. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 3 2003

Mr. Jay M. Patel Director of QA/RA Sciton, Inc. 845 Commercial Street Palo Alto, California 94303

Re: K023881 Trade/Device Name: Profile 1064 Laser Systems and Accessories 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: March 14, 2003 Received: March 17, 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 (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.

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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]. 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) you may obtain. 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,

Sincerery, yours,

Mark A. Milkenan

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): | K023881 |
|---------------------------|---------|
|---------------------------|---------|

Profile 1064 Laser Systems and Accessories Device Name:

## Indications for Use:

The Profile 1064 Laser Systems and Accessories are intended for use in the medical specialties of general and plastic surgery, dermatology, endoscopic/laproscopic general surgery, gastroenterology, gynecology, otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, pulmonary/thoracic surgery and urology for surgical and aesthetic applications.

### Dermatology:

Coagulation and hemostasis of benign vascular lesions such as, but not limited to port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg veins and spider veins. The lasers are also intended for the treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), café au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue/black tattoos) and plaques. Additionally, the lasers are indicated for pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.

Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.

Removal of unwanted hair, for the stable long term, or permanent hair reduction through selective targeting of melanin in hair follicles, and for the treatment for pseudofolliculitis barbae (PFB). The Profile 1064 Laser Systems and Accessories are indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin.

The Profile 1064 Laser Systems and Accessories are indicated for the treatment of facial wrinkles.

The intended use of the contact cooling system in the Profile handpiece is to provide cooling of the skin prior to, during and after laser treatment, for the epidermal protection and reduction of pain during laser treatment, to allow for the use of higher fluences for laser treatments such as hair removal and vascular lesions, and to reduce the potential side effects of laser treatments.

Mark n Millers

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

K023881

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#### Surgical Applications:

Incision/excision and cutting, ablation, coagulation/hemostasis of soft tissue in the performance of surgical applications in endoscopy/laparoscopy, gastroenterology, general surgery, head and neck/otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, plastic surgery, pulmonary/thoracic surgery, gynecology (e.g. menorrhagia) and urology.

# (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)

Over-The-Counter Use

Mark N. Millikan

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

510(k) Number _

OR