(70 days)
Not Found
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 learning components.
Yes
The device is used for "treatment of wrinkles and skin resurfacing," which are therapeutic applications.
No
Explanation: The device description clearly states its purpose is for "excision, incision, ablation, vaporization and coagulation of soft tissue," and explicitly for "treatment of wrinkles and skin resurfacing." These are therapeutic, not diagnostic, actions. There is no mention of analysis, detection, or diagnosis of conditions.
No
The device description clearly states it is a laser handpiece, which is a hardware component, and it emits laser energy.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states the device is a laser handpiece used for surgical procedures on soft tissue and skin (excision, incision, ablation, vaporization, coagulation). This is a direct treatment device, not a diagnostic test performed on a sample.
- Intended Use: The intended use is for treating wrinkles and skin resurfacing, which are therapeutic applications, not diagnostic ones.
Therefore, the Cutera Er:YAG Laser Handpiece falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Cutera Er:YAG Laser System is designed for use in applications requiring the excision, incision, ablation, vaporization and coagulation of soft tissue including treatment of wrinkles and skin resurfacing.
The Cutera Er:YAG Laser Handpiece is designed for use in applications requiring the excision, incision, ablation, vaporization and coagulation of soft tissue.
Indications include: treatment of wrinkles and skin resurfacing.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The Cutera Er: YAG 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 2940nm. 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
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
K 070138
Attachment 5 510(k) Summary for the Cutera Er:YAG Laser System
I. General Information
:
MAR 2 7 2007
| Submitter: | Cutera, Inc.
3240 Bayshore Blvd
Brisbane, CA 94010 |
|-----------------|----------------------------------------------------------|
| Contact Person: | Connie Hoy |
| Telephone: | 415-657-5586 |
| Fax: | 415-330-2443 |
Summary Preparation Date: January, 15, 2007
II. Names
| Device Proprietary Name: | Cutera Er:YAG Laser Handpiece |
|---|---|
| Classification Name: | Instrument, Powered, Laser, GEX |
| Common Name: | Dermatology Laser |
III. Predicate Devices
| • K060033 | Sciton Profile Er:YAG |
|---|---|
| • K032599 | MLT Erbium:YAG |
IV. Product Description/Technological Characteristics
The Cutera Er: YAG 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 2940nm. The water cooled laser is located in the handpiece and utilizes a computer controlled scanner.
V. Statement of Intended Use
The Cutera Er:YAG Laser System is designed for use in applications requiring the excision, incision, ablation, vaporization and coagulation of soft tissue including treatment of wrinkles and skin resurfacing.
1
VI. Rationale for Substantial Equivalence
The Cutera Er:YAG 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:YAG Handpiece is therefore substantially equivalent to the currently marketed predicate devices.
VII. Safety and Effectiveness Information
Technologically, the Cutera Er: YAG Handpiece is substantially equivalent to the listed predicate devices. Therefore the risks and benefits for the Cutera Er:YAG 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:YAG Handpiece was found to be substantially equivalent to currently marketed devices. The Cutera Er:YAG 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 logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and three human figures below it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circle around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 7 2007
Cutera, Inc. % Ms. Connie Hoy VP of RA/QA 3240 Bayshore Boulevard Brisbane, California 94005
Re: K070138
Trade/Device Name: Cutera ER:YAG 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: January 15, 2007 Received: January 19, 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.
3
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.
for
Mark N. Melhorn
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Attachment 4 Indications For Use Statement
510(k) Number (if Known):
Device Name: Cutera Er: YAG Laser Handpiece
Indications for Use:
The Cutera Er:YAG Laser Handpiece is designed for use in applications requiring the excision, incision, ablation, vaporization and coagulation of soft tissue.
Indications include: treatment of wrinkles and skin resurfacing.
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number L070138
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Prescription Use
✓
Over-The-Counter Use _