The Cutera Er: YSGG laser hand piece is designed for use in applications requiring the excision, incision, ablation, vaporization and coagulation of soft tissue. Dermatology and Plastic Surgery Indications include: treatment of wrinkles and skin resurfacing. Opthalmology Indications include: Incision, excision, vaporization and coagulation of tissue surrounding the eye and orbit. The Cutera Fractionated Er:YSGG laser hand piece is designed for use in dermatology for skin resurfacing and for coagulation.

Device Description

The Cutera Er:YSGG Laser handpiece is an optional handpiece for the currently marketed Xeo and Solera Opus laser systems. The handpiece emits laser energy at a wavelength of 2790nm. The water cooled laser is located in the handpiece and utilizes a computer controlled scanner.

AI/ML Overview

This document is a 510(k) summary for the Cutera Er:YSGG Laser Handpiece (K080530). It focuses on establishing substantial equivalence to a predicate device (K063867) rather than providing detailed acceptance criteria and study results for a new device's performance.

Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, and comparative effectiveness studies is not available in this document.

Here's an analysis of what can be extracted from the provided text based on your request:

I. Acceptance Criteria and Device Performance

This document does not present specific acceptance criteria in the form of performance metrics (e.g., accuracy, sensitivity, specificity) for the device. Instead, the "acceptance" is framed around demonstrating substantial equivalence to a predicate device. The performance is assessed by comparing its technological characteristics and intended use to those of the predicate device.

Acceptance Criteria (Implied)	Reported Device Performance
Substantial equivalence to predicate device (K063867) in:	The Cutera Er:YSGG Handpiece is substantially equivalent to K063867.
- Intended Use	- Shares the same general indications for use as K063867.
- Technological Characteristics (wavelength, type of laser etc.)	- Handpiece emits laser energy at 2790nm (same as predicate).
- Safety and Effectiveness	- Risks and benefits are comparable to the predicate devices.
- No new questions of safety or effectiveness	- No new questions of safety or effectiveness are raised.

II. Study Details

As this is a 510(k) summary focused on substantial equivalence, a traditional "study" with a test set, sample size, and ground truth in the context of device performance metrics is not described. The "study" implicitly involves a comparison of specifications and intended use of the new device against the predicate.

Sample size used for the test set: Not applicable/Not provided. The evaluation is based on comparing the device's design and intended use to a predicate.
Data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable/Not provided.

III. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. Ground truth as typically understood for performance studies (e.g., diagnostic accuracy) is not established or discussed in this substantial equivalence document.

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

Not applicable.

V. 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:

Not applicable. This device is a laser handpiece, not an AI-assisted diagnostic tool involving human readers.

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

Not applicable. This is a hardware device.

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

Not applicable. The "ground truth" for substantial equivalence is the existing regulatory status and performance of the predicate device.

VIII. The sample size for the training set:

Not applicable. This document does not describe a training set as it pertains to a machine learning algorithm or a clinical trial.

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

Not applicable.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image contains handwritten text that appears to read "K esc 530". The text is written in a casual, cursive style, with varying stroke thicknesses. The characters are spaced somewhat unevenly, and the overall impression is that of a quick, handwritten note.

Attachment 10 510(k) Summary for the Cutera Er:YSGG Laser System

I. General Information

AUG 1 5 2008

Submitter:	Cutera, Inc.3240 Bayshore BlvdBrisbane, CA 94005
Contact Person:	Kathy Maynor
Telephone:Fax:	415-657-5586415-330-2443

Summary Preparation Date: February 23, 2008

II. Names

Device Proprietary Name:	Cutera Er:YSGG Laser Handpiece
Classification Name:	Instrument, Powered, Laser, GEX
Common Name:	Dermatology Laser

III. Predicate Devices

. K063867 Cutera Er:YSGG Laser Hand Piece

IV. Product Description/Technological Characteristics

V. Statement of Intended Use

Cutera Er: YSGG Laser Hand Piece (K063867 - 4-8 mm spot size)

The Cutera Er:YSGG Laser System is designed for use in applications requiring the excision, incision, ablation, vaporization and coagulation of soft tissue. For

{1}------------------------------------------------

Dermatology and Plastic Surgery, indications include: treatment of wrinkles and skin resurfacing. For Opthalmology, indications include: Incision, excision, vaporization and coagulation of tissue surrounding the cyc and orbit.

Cutera Er: YSGG Laser Hand Piece (K080530) - Fractionated/Small Spot Size

The Cutera Fractionated Er:YSGG laser hand piece is designed for use in dermatology for skin resurfacing and for coagulation.

Rationale for Substantial Equivalence VI.

The Cutera Er:YSGG Handpiece shares the same general indications for use as the currently marketed predicate devices, and does not raise any issues with safety and effectiveness. The Cutera Er:YSGG Handpiece is therefore substantially equivalent to the currently marketed predicate devices.

VII. Safety and Effectiveness Information

Technologically, the Cutera Er:YSGG Handpiece is substantially equivalent to the listed predicate devices. Therefore the risks and benefits for the Cutera Er:YSGG Handpiece are comparable to the predicate devices.

Cutera therefore believes that there are no new questions of safety or effectiveness raised by the introduction of this device.

VIII. Conclusion

The Cutera Er: YSGG Handpiece was found to be substantially equivalent to currently marketed devices. The Cutera Er:YSGG shares similar indications for use, design features, and similar functional features as the currently marketed predicate devices.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Cutera, Inc. % Ms. Kathy Maynor VP of Regulatory/Quality 3240 Bayshore Boulevard Brisbane, California 94005

AUG 1 5 2008

Re: K080530

Trade/Device Name: Cutera Er: YSGG Laser Hand Piece 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 7, 2008 Received: July 17, 2008

Dear Ms. Maynor:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced a bove 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

{3}------------------------------------------------

Page 2 -- Ms. Kathy Maynor

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 desirc 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 M. Wilkerson

Mark N. Melkerson Director Division of General. Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Attachment 2 Indications For Use Statement

K 080530 510(k) Number (if Known):

Device Name: Cutera Er:YSGG Laser Hand Piece

Indications for Use (K063867) – Er:YSGG Laser Hand Piece - 4-8 mm spot size:

The Cutera Er: YSGG laser hand piece is designed for use in applications requiring the excision, incision, ablation, vaporization and coagulation of soft tissue.

Dermatology and Plastic Surgery Indications include: treatment of wrinkles and skin resurfacing

Opthalmology

Indications include: Incision, excision, vaporization and coagulation of tissue surrounding the eye and orbit.

Indications for Use (K080530) -Er: YSGG Laser Hand Piece - Fractionated/Small spot size The Cutera Fractionated Er:YSGG laser hand piece is designed for use in dermatology for skin resurfacing and for coagulation.

Prescription Use __ V OR Over-The-Counter Use

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

Concurrence of G

vision Sign-Cit) Division of General. Restorative, and Neurological Devices

510(k) Number K080530

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.