PROFILE MULTI-PLATFORM SYSTEM

K081352 · Sciton, Inc · GEX · Oct 23, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K081352
• Device Name: PROFILE MULTI-PLATFORM SYSTEM
• Applicant: Sciton, Inc
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Oct 23, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

755 nm Indications for Use: The 755 nm Profile Multi-Platform System with its accessories is indicated for stable long-term, or permanent hair reduction for all skin types (Fitzpatrick I - VI) including tanned skin. It is also indicated for the treatment of vascular lesions, benign pigmented lesions and wrinkles. 1320 nm Indications for Use: The 1320nm Profile Multi-Platform System with its accessories is intended for the surgical incision, excision, vaporization, ablation, and coagulation of soft tissue. Soft tissue includes skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands. The Profile 1320nm laser is further indicated for laser assisted lipolysis. 2940 nm Indications for Use: The 2940 nm Profile Multi-Platform System with Profractional handpiece and delivery system is intended for use in dermatological procedures requiring skin resurfacing and coagulation of soft tissue.

Device Story

Modular, multi-wavelength laser/light system; delivers thermal energy via scanning and focusing optics. Components: control console, power supply, cooling system, fiber optic/articulated arm delivery system, handpieces/scanners. Used in clinical settings by physicians for dermatological and surgical procedures. Transforms electrical energy into specific laser wavelengths (755nm, 1320nm, 2940nm) to target soft tissue, hair follicles, or vascular/pigmented structures. Output allows for precise tissue interaction (ablation, coagulation, lipolysis). Clinical benefit: effective hair reduction, skin resurfacing, and surgical tissue management.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and predicate device comparison (bench testing only).

Technological Characteristics

Modular multi-wavelength laser system. Wavelengths: 755 nm, 1320 nm, 2940 nm. Delivery: fiber optic or articulated arm with handpieces/scanners. Includes power supply, cooling system, and control console. Energy source: laser/light. Functionality: adjustable power output, repetition rate, energy, spot size, and fluence.

Indications for Use

Indicated for permanent hair reduction (all Fitzpatrick skin types I-VI, including tanned), treatment of vascular/pigmented lesions, and wrinkles (755 nm). Indicated for surgical incision, excision, vaporization, ablation, coagulation of soft tissue, and laser-assisted lipolysis (1320 nm). Indicated for skin resurfacing and soft tissue coagulation (2940 nm).

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 Multi-Platform Laser System and Accessories (K070388)
• ULTRAWAVE II EX 1320 (K070805)
• ARION Laser System (K042474)
• Cynosure Apogee Elite Laser (K034030)
• GentleLASE Family of Laser Systems (K024371)
• GentleLASE Family of Laser Systems (K024260)
• Cynosure Smartlipo Multiwavelength Laser (K080121)
• CoolTouch NS160 CoolLipo Nd:YAG Surgical Laser (K072751)
• Ceralas D 980nm Diode Laser System (Models D15, D25) (K072779)

Submission Summary (Full Text)

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## Attachment IV

# 510(k) Summary

OCT 2 3 2008

| Submitter: | Sciton, Inc. |
|----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 925 Commercial Street, Palo Alto, CA 94303 |
| Phone: | [phone] |
| Fax : | [phone] |
| Contact Person: | Jay M. Patel, VP of Regulatory Affairs |
| Date Prepared: | October 21, 2008 |
| Device Trade Name: | Profile Multi-Platform System |
| Common Name: | Laser/Light Powered Surgical Device (and Accessories) |
| Classification Name: | Laser Surgical Instrument, 21 CFR 878.4810. |
| Legally Marketed<br>Predicate Device: | K070388: Profile Multi-Platform Laser System and Accessories<br>K070805: ULTRAWAVE II EX 1320<br>K042474: ARION Laser System<br>K034030: Cynosure Apogee Elite Laser<br>K024371: GentleLASE Family of Laser Systems<br>K024260: GentleLASE Family of Laser Systems<br>K080121: Cynosure Smartlipo Multiwavelength Laser<br>K072751: CoolTouch NS160 CoolLipo Nd:YAG Surgical Laser<br>K072779: Ceralas D 980nm Diode Laser System (Models D15, D25) |
| Description of<br>Profile Multi-Platform<br>System | The Profile Multi-Platform System is a modular, multi-wavelength laser/light system.<br>The system uses scanning and focusing optics to deliver a pattern of thermal<br>energy to the treatment site. The system consists of control console which houses the<br>power supply, cooling system, fiber optic delivery system and/or articulated arm<br>delivery system with handpiece and/or scanner. |
| Intended Use: | 755 nm Indications for Use:<br>The 755 nm Profile Multi-Platform System with its accessories is indicated for<br>stable long-term, or permanent hair reduction for all skin types (Fitzpatrick I - VI)<br>including tanned skin. It is also indicated for the treatment of vascular lesions,<br>benign pigmented lesions and wrinkles.<br>1320 nm Indications for Use:<br>The 1320nm Profile Multi-Platform System with its accessories is intended for the<br>surgical incision, excision, vaporization, ablation, and coagulation of soft tissue.<br>Soft tissue includes skin, cutaneous tissue, subcutaneous tissue, striated and<br>smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels<br>and nodes, organs and glands. The Profile 1320nm laser is further indicated for<br>laser assisted lipolysis.<br>2940 nm Indications for Use:<br>The 2940 nm Profile Multi-Platform System with Profractional handpiece and<br>delivery system is intended for use in dermatological procedures requiring skin<br>resurfacing and coagulation of soft tissue. |
| Technological<br>Characteristics | The Profile Multi-Platform System shares the same indications for use, similar design<br>features (including wavelength, laser/light medium and delivery systems, power<br>supply, cooling and control system), functional features (including power output,<br>repetition rate, energy, spot size and fluence), and is therefore substantially<br>equivalent to the above legally marketed predicate devices. |
| Safety and<br>Effectiveness | The indications for use are based upon the indications for use for predicate systems.<br>Technologically, the Profile Multi-Platform System is substantially equivalent to the<br>listed predicate devices. Therefore, the risks and benefits for the Profile Multi-Platform<br>System are comparable to the predicate devices. |
| Conclusion | The Profile Multi-Platform System shares similar indications for use, design features,<br>and similar functional features as, and therefore is substantially equivalent to the<br>currently marketed predicate devices. |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Sciton, Inc. % Mr. Jay M. Patel VP of Regulatory Affairs 925 Commercial Street Palo Alto, California 94303

OCT 2 3 2008

Re: K081352

Trade/Device Name: Profile Multi-Platform System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and and in dermatology Regulatory Class: II Product Code: GEX Dated: September 5, 2008 Received: September 5, 2008

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

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Page 2 - Mr. Jay M. Patel

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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 vours.

Mark N. Millman

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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### Attachment III

### Statement of Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ K081352

Profile Multi-Platform System Device Name:

Indications for Use:

### 755 nm Indications for Use:

The 755 nm Profile Multi-Platform System with its accessories is indicated for stable long-term, or permanent hair reduction for all skin types (Fitzpatrick I -VI) including tanned skin. It is also indicated for the treatment of vascular lesions, benign pigmented lesions and wrinkles.

### 1320 nm Indications for Use:

The 1320nm Profile Multi-Platform System with its accessories is intended for the surgical incision, excision, vaporization, ablation, and coagulation of soft tissue. Soft tissue includes skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands. The Profile 1320nm laser is further indicated for laser assisted lipolysis.

### 2940 nm Indications for Use:

The 2940 nm Profile Multi-Platform System with Profractional handpiece and delivery system is intended for use in dermatological procedures requiring skin resurfacing and coagulation of soft tissue.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21CFR801)

OR Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number K081352