ISOLAZ

K083730 · Aesthera Corporation · GEX · Jan 9, 2009 · General, Plastic Surgery

Device Facts

• Record ID: K083730
• Device Name: ISOLAZ
• Applicant: Aesthera Corporation
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jan 9, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Isolaz™ is intended to treat benign vascular and pigmented lesions, permanent hair reduction, mild to moderate acne, including pustular acne, comedonal acne and mild to moderate inflammatory acne (acne vulgaris) in all skin types (Fitzpatrick I-VI).

Device Story

Isolaz™ is a portable tabletop system delivering non-coherent intense pulsed light (IPL) via a photopneumatic handpiece. It emits light in the 400-1200nm range. The operator manually sets power and delivery time via the main console. The device is used in clinical settings by healthcare professionals. By combining light therapy with pneumatic suction, the device targets vascular/pigmented lesions, reduces hair, and treats acne. The output is controlled by the clinician to achieve therapeutic effects on the skin, aiding in the management of dermatological conditions.

Clinical Evidence

Bench testing only. The manufacturer conducted product testing to evaluate conformance to specifications, confirming the system met all established requirements.

Technological Characteristics

Portable tabletop IPL system; non-coherent light source (400-1200nm); photopneumatic delivery handpiece; manual operator control for power and pulse duration; materials are biocompatible and previously cleared in similar devices.

Indications for Use

Indicated for treatment of benign vascular and pigmented lesions, permanent hair reduction, and mild to moderate acne (pustular, comedonal, and inflammatory/acne vulgaris) in 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 Photopneumatic PPx™ System (K062048)

Submission Summary (Full Text)

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K083730

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JAN - 9 2009

## Section 5

## 510(k) Summary

General Information Classification

Trade Name

Submitter

Contact

Class II

Isolaz™ Intense Pulsed Light System

Aesthera 6634 Owens Drive Pleasanton, CA 94588 877 275 4779 Tel: [phone] Fax:

Pamela M. Buckman, MSN Consultant Buckman Company, Inc. 1070 Concord Ave., Suite 230 Concord, CA 94520 Tel: [phone] 356 2654 Fax:

#### Intended Use

The Isolaz™ is intended to treat benign vascular and pigmented lesions, permanent hair reduction, mild to moderate acne, including pustular acne, comedonal acne and mild to moderate inflammatory acne (acne vulgaris) in all skin types (Fitzpatrick I-VI).

#### Predicate Devices

Aesthera Photopneumatic PPx™ System K062048

#### Device Description

The Isolaz™ System is a portable tabletop system used to deliver non-coherent 400-1200nm, 530-12000mm and 580-1200mm intense pulsed light via a delivery handpiece utilizing photpneumatic technology. The system consists of a main console, a treatment handpiece and a footswitch. The desired power and delivery time are set manually by the operator.

#### Materials

All materials used in the manufacture of the Isolaz™ are suitable for this use and have been used in numerous previously cleared products.

Testing

Product testing was conducted to evaluate conformance to product specification. The results showed the system met specification.

### Summary of Substantial Equivalence

The Isolaz™ System is equivalent to the predicate product. The indications for use, basic overall function, methods of manufacturing, and materials used are substantially equivalent.

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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 circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". Inside the circle is an abstract symbol of an eagle, with its wings spread and head turned to the left. The eagle is composed of thick, black lines.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

### JAN - 9 2009

Aesthera Corporation % Buckman Company, Inc. Ms. Pamela M. Buckman, MSN President 1070 Concord Avenue, Suite 230 Concord, California 94520

Re: K083730

Trade/Device Name: Isolaz™ 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: December 15, 2008 Received: December 16, 2008

Dear Ms. Buckman:

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. Pamela M. Buckman, MSN

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 yours.

Mark H Millican

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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## Section 4

# Indications for Use Statement

510(k) Number:

#### K 083730 Pending.

Isolaz™ System

Device Name:

Indications for Use:

The Isolaz™ System is designed to treat benign vascular and pigmented lesions, permanent hair reduction, mild to moderate acne, including pustular acne, comedonal acne and mild to moderate inflammatory acne (acne vulgaris) in all skin types (Fitzpatrick I-VI).

X Prescription Use (Per 21 CFR 801 Subpart D)

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)

OR

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

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