AURA ISURGICAL LASER SYSTEM & ACCESSORIES by LASERSCOPE

This document is a 510(k) summary for the Aura™ i Surgical Laser System & Accessories, indicating it's a submission for market clearance rather than a detailed study report. Therefore, it does not contain the acceptance criteria or a study proving the device meets specific performance criteria in the way you've outlined for clinical performance studies.

Instead, this document focuses on establishing substantial equivalence to predicate devices based on shared indications for use, design, and functional features, and adherence to performance standards for medical laser systems (21 CFR 1040.10 and 1040.11).

Therefore, I cannot provide a table of acceptance criteria or details about a study proving the device meets that criteria based on the provided text. The document is essentially a regulatory filing for market clearance, not a clinical trial report.

However, I can extract information related to the device and its intended use:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: Not explicitly stated as clinical performance metrics (e.g., reduction in lesion count by X% in Y% of patients). Instead, the regulatory acceptance criteria for this 510(k) submission are that the device is substantially equivalent to legally marketed predicate devices and conforms to federal regulations and performance standards for medical laser systems (21 CFR 1040.10 and 1040.11).
Reported Device Performance: The document states the device is "indicated to treat moderate inflammatory acne vulgaris." No specific clinical performance statistics (e.g., efficacy rates, adverse event rates, or comparative outcomes) are provided in this summary.

2. Sample Size Used for the Test Set and Data Provenance:

Not applicable. This document does not describe a clinical study with a test set of patients for evaluating the device's efficacy or performance in a clinical setting. It's a regulatory submission for substantial equivalence.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable. See point 2.

4. Adjudication Method for the Test Set:

Not applicable. See point 2.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size:

No. This document does not mention any MRMC study or any comparative effectiveness study with human readers (as would be relevant for diagnostic AI).

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

No. This device is a physical surgical laser system, not an AI algorithm.

7. The type of ground truth used:

Not applicable. As this is a medical device and not a diagnostic AI tool, the concept of "ground truth" for a test set in the same way is not relevant here. The "truth" for its claims relies on its physical and functional similarity to already cleared devices and adherence to laser safety standards.

8. The sample size for the training set:

Not applicable. This document describes a physical medical device, not an AI model that requires a training set.

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

Not applicable. See point 8.

In summary: This 510(k) submission establishes the regulatory pathway for marketing the Aura™ i Surgical Laser System by demonstrating substantial equivalence to predicate devices and compliance with relevant safety standards. It does not present clinical trial data or performance against specific clinical acceptance criteria in the format you requested.

Summary

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Ko24206 1/2

NOV. 1 7 2003

510(k) Summary Statement For the AURA™ i Surgical Laser System & Accessories for the Treatment of Moderate Acne vulgaris

General Information

A. Trade Name Aura™ i Surgical Laser System & Accessories
B. Common Name Laser Instrument, Surgical, Powered
C. Establishment Registration Number

2937094

D. Manufacturer's Identification
Laserscope 3070 Orchard Drive San Jose, CA 95134-2011 (408) 943-0636 (503) 961-1688 FAX

Official Correspondent Paul Hardiman Manager, Regulatory Affairs/Clinical Affairs

E. Device Classification
The Aura i Surgical Laser System has been specifically classified as a Class II medical device by the OB/GYN, General Plastic Surgery, and ENT Device Advisory Panels.
F. Performance Standards
The Aura i Surgical Laser System conforms with federal regulations and the performance standards 21 CFR 1040.10 and 1040.11 for medical laser systems.
G. Predicate Devices:
- Laserscope Aura™ Laser System and Accessories ●
- Clearlight Phototherapy System Model C420 (ClearLight™, Lumenis) .

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H. Product Description:

The Laserscope Aura i Surgical Laser System & Accessories are comprised of the following main components:

A Laser Console ●
A Fiber Port (for Delivery Devices) 0
Control and Display Panels .
Operating Software ●
Footswitch and Handswitch Delivery Controls .
. Accessories
A Cooling Sub-system ●
1. Indications For Use:

The Laserscope Aura i Laser System is indicated to treat moderate inflammatory acne vulgaris.

. ل. Rationale for Substantial Equivalence
The Laserscope Aura i Laser System & Accessories and the ClearLight Phototherapy System, Model CL 420 share the same indications for use, similar design features, functional features, and therefore are substantially equivalent to: Laserscope Lyra Laser System and Accessories; and, the Modified Coherent VersaPulse Select Wavelength (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers and Delivery Devices and Accessories. Details are provided in the Substantial Equivalence Section of this submission.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is depicted with three intertwined strands and a single wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus.

NOV 17 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Paul H. Hardiman Manager, Regulatory Affairs Laserscope 3070 Orchard Drive San Jose, California 95134-2011

Re: K024206

Trade/Device Name: Aura™i Surgical Laser System 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: September 16, 2003 Received: September 17, 2003

Dear Mr. Hardiman:

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 (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.

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Page 2 - Mr. Paul H. Hardiman

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 (301) 594-4659. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Miriam C. Provost

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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INDICATIONS FOR USE STATEMENT

Page 1

510(k) Number:

027206

Device Name:

AURA i SURGICAL LASER SYSTEM & ACCESSORIES

INTENDED USE:

The Laserscope Aura i Laser System & Accessories is indicated to treat moderate inflamatory acne vulgaris.

(Please Do Not WRITE BELOW THIS LINE - Continue on another Page)

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use: or Over The-Counter-Use (per 21 CFR 801.109)

Miriam C. Provost

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

510(k) Number K024206

000002

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.