(171 days)
No
The summary describes a laser handpiece with a computer-controlled scanner, but there is no mention of AI, ML, image processing, or any data-driven algorithms for decision making or analysis.
Yes
The device is described as "designed for use in applications requiring the excision, incision, ablation, vaporization and coagulation of soft tissue," and specifically for "treatment of wrinkles and skin resurfacing" in dermatology and plastic surgery, and "incision, excision, vaporization and coagulation of tissue surrounding the eye and orbit" in ophthalmology, which are all therapeutic applications.
No
The device description and intended use clearly state that this is a laser handpiece designed for surgical applications like excision, incision, ablation, vaporization, and coagulation of soft tissue, as well as skin resurfacing. These are therapeutic or treatment functions, not diagnostic ones.
No
The device description explicitly states it is a "handpiece" which is a physical hardware component of a laser system. It also mentions a "water cooled laser" located within the handpiece and a "computer controlled scanner," all of which are hardware elements.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a laser handpiece for surgical procedures involving the excision, incision, ablation, vaporization, and coagulation of soft tissue. These are all in vivo procedures, meaning they are performed on a living organism.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. This device does not perform any such tests on samples.
- Device Description: The description confirms it's a laser handpiece emitting energy for surgical applications.
- Anatomical Site: The anatomical sites listed (soft tissue, skin, eye and orbit) are all parts of the living body.
Therefore, the Cutera Er: YSGG laser handpiece is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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 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.
Product codes
GEX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft tissue, skin, eye, orbit
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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 Blvd
Brisbane, CA 94005 |
|--------------------|----------------------------------------------------------|
| Contact Person: | Kathy Maynor |
| Telephone:
Fax: | 415-657-5586
415-330-2443 |
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
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.
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.
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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
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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
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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