AESTHERA PHOTOPNEUMATIC (PPX) SYSTEM

K062048 · Aesthera Corporation · GEX · Sep 7, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K062048
• Device Name: AESTHERA PHOTOPNEUMATIC (PPX) SYSTEM
• Applicant: Aesthera Corporation
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Sep 7, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Aesthera Photopneumatic™ (PPx™) System is intended for: - The treatment of benign vascular and pigmented lesions; - Permanent hair reduction; - The treatment of mild to moderate acne, including pustular acne, comedonal acne, and mild to moderate inflammatory acne (acne vulgaris). The Aesthera Photopneumatic™ (PPx™) System is intended for use on all skin types (Fitzpatrick skin types I-VI).

Device Story

Portable tabletop system delivering intense pulsed light (IPL) via Photopneumatic technology; utilizes treatment handpiece with IntelliTip™; light emission occurs only when tip is sealed against patient skin. System components include main console, treatment handpiece, optional coolant accessory (cryogenic, water, or air spray), and footswitch. Operated by clinicians in a professional setting; user interface and controls integrated into handpiece for ergonomics. Device treats vascular/pigmented lesions, reduces hair, and clears acne. Light containment within IntelliTip™ ensures safety during application. Clinical benefit includes non-invasive dermatological treatment across all Fitzpatrick skin types.

Clinical Evidence

Clinical data provided demonstrating safety and effectiveness for the treatment of mild to severe acne, including pustular, comedonal, and inflammatory acne (acne vulgaris).

Technological Characteristics

Portable tabletop IPL system; utilizes Photopneumatic technology; handpiece-integrated controls; optional coolant accessory (cryogenic, water, or air spray); IntelliTip™ light delivery interface; intended for all Fitzpatrick skin types (I-VI).

Indications for Use

Indicated for treatment of benign vascular and pigmented lesions, permanent hair reduction, and treatment of mild to moderate acne (pustular, comedonal, inflammatory/acne vulgaris) in patients of all skin types (Fitzpatrick I-VI).

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

• Aesthera AIP Intense Pulsed Light System (K041554)
• Radiancy Acne System with ClearTouch Light Unit Assembly (K051268)
• Radiancy Skin Station with Modified Light Unit Assembly for Psoriasis System (K052442)
• Radiancy ClearTouch Lite Acne Clearance System (K060411)
• Palomar Lux V Pulsed Light Handpiece for StarLux Systems (K040081)
• Palomar StarLux Pulsed Light System (K041086)
• Novalis Clareon & Solarus Pulsed Light Systems w/ AR Handpiece (K043319)

Submission Summary (Full Text)

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SEP - 7 2006

## Section 5 - 510(k) Summary or Stock) Statement

#### I. General Information

Submitter:

Aesthera Corporation 6634 Owens Drive Pleasanton, CA 94588 USA

Contact Person:

Chief Technical Officer

Robert Anderson

Summary Preparation Date: July 18, 2006

#### II. Names

Device Names: Aesthera Photopneumatic™ (PPx™) System

Primary Classification Names: Accessory for, Laser Powered Surgical Instruments

#### III. Predicate Devices

- Aesthera AIP Intense Pulsed Light System (K041554); .
- Radiancy Acne System with ClearTouch Light Unit Assembly (K051268); .
- Radiancy Skin Station with Modified Light Unit Assembly for Psoriasis System . (K052442);
- . Radiancy ClearTouch Lite Acne Clearance System (K060411);
- Palomar Lux V Pulsed Light Handpiece for StarLux Systems (K040081); .
- � Palomar StarLux Pulsed Light System (K041086);
- Novalis Clareon & Solarus Pulsed Light Systems w/ AR Handpiece (K043319) �

#### IV. Product Description

The Aesthera Photopneumatic™ (PPx™) System is comprised of the following main components:

- . Main console
- PPx™ Treatment Handpiece .
- Optional coolant accessory cryogenic, water, or air spray for cooling the handpiece . tip; and
- . Treatment Footswitch.

The Aesthera Photopneumatic™ (PPx™) System (with treatment handpiece) is a portable tabletop system used to deliver intense pulsed light to the patient treatment site via a delivery handpiece utilizing Photopneumatic technology. Intense pulsed light is emitted through the IntelliTip™ only when the tip is sealed against the selected patient treatment All emitted light is contained within the IntelliTip™ during treatment. site. The handpiece is uniquely designed to promote increased ergonomics with all user interface and controls located on the handpiece.

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#### V. Indications for Use

The Aesthera Photopneumatic™ (PPx™) System is intended for:

- The treatment of benign vascular and pigmented lesions: .
- Permanent hair reduction; .
- The treatment of mild to moderate acne, including pustular acne, comedonal acne, . and mild to moderate inflammatory acne (acne vulgaris).

The Aesthera Photopneumatic™ (PPx™) System is intended for use on all skin types (Fitzpatrick skin types I-VI).

#### Rationale for Substantial Equivalence VI.

The Aesthera Photopneumatic™ (PPx™) System shares the same or similar indications for use, device operation, overall technical and functional capabilities, and therefore is substantially equivalent to the predicate devices.

#### Safety and Effectiveness Information VII.

The review of the indications for use and technical characteristics and the published medical literature provided demonstrates that the Aesthera Photopneumatic™ (PPx™) System is substantially equivalent to the predicate devices. Clinical data demonstrating the safety and effectiveness of the Aesthera Photopneumatic™ (PPx™) System for the treatment of mild to severe acne, including pustular acne, comedonal acne, and mild to moderate inflammatory acne (acne vulgaris) was provided.

# VIII. Conclusion

The Aesthera Photopneumatic™ (PPx™) System was found to be substantially equivalent to the predicate devices.

The Aesthera Photopneumatic™ (PPx™) System shares the same or similar indications for use, similar design features, and functional features with, and thus is substantially equivalent to, the predicate devices.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 7 2006

Aesthera Corporation % AL Voss Associates Ms. Anne Worden Regulatory Consultant 3637 Bernal Avenue Pleasanton, California 94566

Re: K062048

Trade/Device Name: Aesthera Photopneumatic™ (PPx"") 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: July 18, 2006 Received: July 20, 2006

Dear Ms. Worden:

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 -- Ms. Anne Worden

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 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/industry/support/index.html.

Sincerely yours.

for Palo Shup
N. Melkerson

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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### Indications for Use Statement

510(k) Number (if known): K062048

Device Name: Aesthera PhotopneumaticTM (PPxTM) System

Indications for Use:

The Aesthera Photopneumatic™ (PPx™) System is intended for:

- The treatment of benign vascular and pigmented lesions; .
- Permanent hair reduction; .
- The treatment of mild to moderate acne, including pustular acne, comedonal acne, and mild . to moderate inflammatory acne (acne vulgaris).

The Aesthera Photopneumatic™ (PPx™) System is intended for use on all skin types (Fitzpatrick skin types I-VI).

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

**(Division Sign-Off)**

Division of General, Restorative, and Neurological Devices a

510(k) Number K062048