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 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.

AI/ML Overview

The provided text is a 510(k) summary for the Isolaz™ Intense Pulsed Light System. This document focuses on establishing substantial equivalence to a predicate device, rather than detailed clinical study results with acceptance criteria.

Therefore, the document does not contain the information requested to comprehensively describe the acceptance criteria and the study that proves the device meets them, according to your specific points.

Here's a breakdown of what is and isn't present in the provided text:

1. A table of acceptance criteria and the reported device performance:

Not present. The document states "Product testing was conducted to evaluate conformance to product specification. The results showed the system met specification." However, it does not elaborate on what those specifications or acceptance criteria were, nor does it provide a table of performance metrics.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

Not present. This document doesn't detail any clinical test sets or their characteristics.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

Not present. There is no mention of ground truth establishment by experts for a test set.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not present.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

The Isolaz™ is an Intense Pulsed Light system, not an AI-powered diagnostic device that would typically involve human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and not mentioned.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

The Isolaz™ is a physical medical device for treatment, not an algorithm. Therefore, a standalone algorithm performance study is not applicable and not mentioned.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not present.

8. The sample size for the training set:

Not present. The document does not describe a training set as would be relevant for an AI/ML model.

9. How the ground truth for the training set was established:

Not present.

In summary:

The provided K083730 510(k) summary is a regulatory filing for a medical device that demonstrates substantial equivalence to a predicate device. It focuses on the device's intended use, basic function, manufacturing methods, and materials, asserting that product testing confirmed conformance to general specifications. It does not include the detailed clinical study data, acceptance criteria, or ground truth establishment methodologies that would be required to answer your specific questions, which are more relevant to diagnostic devices, particularly those involving AI/ML.

Summary

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K083730

4 1

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: 925 737 2197 Fax:

Pamela M. Buckman, MSN Consultant Buckman Company, Inc. 1070 Concord Ave., Suite 230 Concord, CA 94520 Tel: 925 980 7007 925 356 2654 Fax:

Intended Use

Predicate Devices

Aesthera Photopneumatic PPx™ System K062048

Device Description

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 (240) 276-0115. 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 (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (800) 638-2041 or (240) 276-3150 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)

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

510(k) Number Page 7 of 18

Regulation Number and Section

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
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.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.