(88 days)
The Cutera Er: YSGG Laser Handpiece 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 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.
The provided text does not contain information related to specific acceptance criteria, device performance metrics, or details of a study that proves the device meets such criteria.
The document is a 510(k) summary for the Cutera Er:YSGG Laser System, which focuses on demonstrating substantial equivalence to existing predicate devices, rather than presenting a performance study against predefined acceptance criteria.
The key points from the provided text are:
- Subject: Cutera Er:YSGG Laser Handpiece
- Purpose: To demonstrate substantial equivalence to predicate devices (Sciton Profile Er:YAG, BioLase Oculase MD, MLT Erbium:YAG, BioLase Waterlase).
- Rationale for Substantial Equivalence: The device shares similar indications for use, design features, and functional features as predicate devices, and is not believed to raise new questions of safety or effectiveness.
- Intended Use: Excision, incision, ablation, vaporization, and coagulation of soft tissue for dermatology/plastic surgery (wrinkles, skin resurfacing) and ophthalmology (tissue surrounding the eye and orbit).
Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert qualifications, as it is not present in the provided 510(k) summary. This type of information is typically found in clinical trial reports or detailed validation studies, which are not included in this document.
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Attachment 5 510(k) Summary for the Cutera Er:YSGG Laser System
I. General Information
MAR 2 7 2007
| Submitter: | Cutera, Inc.3240 Bayshore BlvdBurlingame, CA 94010 |
|---|---|
| Contact Person: | Connie Hoy |
Telephone: 415-657-5586 415-330-2443 Fax:
Summary Preparation Date: December 30, 2006
II. Names
| Device Proprietary Name: | Cutera Er:YSGG Laser Handpiece |
|---|---|
| Classification Name: | Instrument, Powered, Laser, GEXOpthalmic Laser, HQF |
| Common Name: | Dermatology LaserOpthalmic Laser |
III. Predicate Devices
| K060033 | Sciton Profile Er:YAG |
|---|---|
| K062354 | BioLase Oculase MD |
| K032599 | MLT Erbium:YAG |
| K031140 | BioLase Waterlase |
IV. Product Description/Technological Characteristics
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.
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Premarket Notification 510(k) Submission: Cutera Er: YSGG Laser Handpiece
V. Statement of Intended Use
The Cutera Er: YSGG Laser System is designed for use in applications requiring the excision, incision, ablation, vaporization and coagulation of soft tissue. For Dermatology and Plastic Surgery, indications include: treatment of wrinkles and skin For Opthalmology, indications include: Incision, excision, vaporization resurfacing. and coagulation of tissue surrounding the eye and orbit.
VI. Rationale for Substantial Equivalence
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. There are no unique applications, indication, materials or specification presented in this application. 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.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with outstretched wings, positioned to the right of the text. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the left side of the bird figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Cutera, Inc. % Ms. Connie Hoy VP of RA/QA 3240 Bayshore Boulevard Brisbane, California 94005
MAR 2 7 2007
Re: K063867
Trade/Device Name: Cutera ER:YSGG Laser Handpiece 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: February 21, 2007 Received: February 22, 2007
Dear Ms. Hoy:
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 – Ms. Connie Hoy
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 (240) 276-0115. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
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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Attachment 4 Indications For Use Statement
510(k) Number (if Known):
Device Name: Cutera Er: YSGG Laser Handpiece
Indications for Use:
The Cutera Er: YSGG Laser Handpiece 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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | |
|---|---|
| ------------------ | -------------------------------- |
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
OR
| 510(k) Number | |
|---|---|
| Over-The-Counter Use |
§ 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.