(116 days)
The Cutera GenesisPlus Nd:YAG laser is intended for use in the medical specialties of general and plastic surgery, dermatology, endoscopic.laproscopic general surgery, gastroenterology, gynecology, otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, pulmonary.thoracic surgery, podiatry and urology for surgical and aesthetic applications.
Dermatology:
The Cutera GenesisPlus laser is intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, rosacea/ diffuse redness, poikiloderma of civatte, scar reduction (including hypertropic and keloid scars), and warts.
The Cutera GenesisPlus laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles.
The GenesisPlus laser is indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin.
Podiatry:
Podiatry (ablation, vaporization, incision, excision, and coagulation of soft tissue) including:
- Matrixectomy
- Periungual and subungual warts
- Plantar warts
- Radical nail excision
- Neuromas
The Cutera GenesisPlus laser is indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes, Trichophyton rubrum and T. mentagrophytes, and/or yeast Candida Albicans, etc.).
The Cutera GenesisPlus Laser unit and controls are contained in a single console. Electrical power is supplied to the console by the facility's power source. Laser energy produced within the device is delivered to the tissue by means of a handpiece using a fiber optic delivery system with an optical lens at the aperture. The user activates laser emission by means of a footswitch.
The Cutera GenesisPlus Laser is designed to provide laser energy for use in a variety of dermatology and podiatry procedures.
Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and supporting studies for the Cutera GenesisPlus Laser System:
Summary of Findings:
The provided document, a 510(k) Summary for the Cutera GenesisPlus Laser System, explicitly states "Performance Data: None" and "Results of Clinical Study: None." This means that traditional acceptance criteria based on clinical performance metrics and their verification through clinical trials are not presented in this summary.
Instead, the submission relies on the concept of substantial equivalence to predicate devices. This regulatory pathway allows new devices to be marketed without new clinical trials if they are demonstrated to be as safe and effective as a legally marketed device (the predicate). The acceptance criteria in this context are primarily based on the technological characteristics being comparable to the predicate devices and the indications for use being similar.
1. Table of Acceptance Criteria and Reported Device Performance
As noted, the provided document does not contain an "acceptance criteria" table in the traditional sense of clinical performance metrics. The "performance" being demonstrated here is the device's technological equivalence to predicate devices.
| Feature/Criterion (Based on Predicate Equivalence) | Cutera GenesisPlus Laser Performance |
|---|---|
| Wavelength | 1064nm Nd:YAG |
| Aiming Beam | 630-680nm (≤ 2.5mW) |
| Energy per Pulse | 20-3500 mJ |
| Fluence | ≤ 25.5 J/cm² (with 1mm spot) |
| Max Power | ≤ 100W |
| Pulse Duration | 100 - 3000μs |
| Spot Size | 1mm (Podiatry), Up to 13mm (other indications) |
| Output Mode | Pulsed |
| Repetition Rate | 5 - 100 Hz |
| Laser Media | Flashlamp pumped solid state rod |
| User Interface | LCD color touchscreen |
| Indications for Use (General & Specific) | Equivalent to predicate devices (as detailed in the document) |
| Technological Characteristics | Equivalent to predicate devices |
Study Proving Device Meets Acceptance Criteria:
The "study" proving the device meets the acceptance criteria is the 510(k) submission itself, which demonstrates substantial equivalence to "PinPointe Footlaser K09354 and K093545" and "Cutera Nd:YAG Laser K0222226." The core of this "proof" is a comparison of technological specifications and intended uses, rather than a clinical performance study. The conclusion explicitly states: "The Cutera GenesisPlus Laser is substantially equivalent in terms of indication for use and technology based on technical characteristics."
Detailed Responses to Specific Questions:
- A table of acceptance criteria and the reported device performance:
- Addressed in the table above. The "acceptance criteria" are implied by the features of the predicate devices against which technological equivalence is being claimed.
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable. The document explicitly states "Performance Data: None" and "Results of Clinical Study: None." Therefore, there was no test set of patients/data in a clinical study to establish performance metrics. The data provenance and sample size for such a test set are irrelevant in this specific 510(k) submission for this device.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable. As no clinical study results or performance data are presented, there was no "test set" requiring ground truth established by experts.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No test set or clinical study was conducted, so no adjudication method was used or is described.
- 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 system, not an AI-assisted diagnostic tool or an imaging device requiring human readers or AI. Therefore, an MRMC study is not relevant to this submission.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a laser system and does not involve an algorithm working in a standalone capacity.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. There was no clinical study or test set for which ground truth was established, as the submission relies on substantial equivalence based on technological characteristics and intended use.
- The sample size for the training set:
- Not applicable. No clinical study data (or any other form of data for training purposes in the context of performance) is mentioned as being used for this 510(k) submission.
- How the ground truth for the training set was established:
- Not applicable. No training set or ground truth for it is mentioned in this submission.
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Attachment 5 510{K) Summary Cutera GenesisPlus Laser System
APR - 5 2011
This 510(K) Summary of safety and effectiveness for the Cutera GenesisPlus Laser is submitted in accordance with the requirements of the SMDA 1990 and following guidance concerning the organization and content of a 510(K) summary.
| Applicant: | Cutera, Inc. |
|---|---|
| ------------ | -------------- |
Address:
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..............................................................................................................................................................................
4.2.2
... .. .. .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
:
3240 Bayshore Blvd.
Connie Hoy
Brisbane, CA 94005
415-657-5592 - phone
Instrument, Surgical, Powered, laser
PinPointe Footlaser K09354 and K093545
79-GEX, 21 CFR 878-48
Cutera Nd:YAG Laser K0222226
415-715-3592 - fax
Contact Person:
Telephone: Fax: Email:
Preparation Date: November 24, 2010
Device Trade Name: Cutera GenesisPlus Laser System
Common Name: Nd:YAG Laser
Classification Name:
Legally Marketed Predicate Device:
Description of the Cutera GenesisPlus Laser:
The Cutera GenesisPlus Laser unit and controls are contained in a single console. Electrical power is supplied to the console by the facility's power source. Laser energy produced within the device is delivered to the tissue by means of a handpiece using a fiber optic delivery system with an optical lens at the aperture. . The user activates laser emission by means of a footswitch.
The Cutera GenesisPlus Laser is designed to provide laser energy for use in a variety of dermatology and podiatry procedures.
Intended use of the Cutera GenesisPlus Laser System: The Cutera GenesisPlus Nd:YAG laser is intended for use in the medical specialties of general and plastic surgery, dermatology, endoscopic.laproscopic general surgery, gastroenterology, gynecology, otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, pulmonary.thoracic surgery, podiatry and urology for surgical and aesthetic applications.
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Attachment 5 510(K) Summary Cutera GenesisPlus Laser System
Specific Indications:
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Dermatology:
The Cutera GenesisPlus laser is intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, rosacea/ diffuse redness, poikiloderma of civatte, scar reduction (including hypertropic and keloid scars), and warts.
The Cutera GenesisPlus laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles.
The GenesisPlus laser is indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin.
Podiatry:
Podiatry (ablation, vaporization, incision, excision, and coagulation of soft tissue) including:
- . Matrixectomy
- . Periungual and subungual warts
- Plantar warts .
- Radical nail excision .
- . Neuromas
The Cutera GenesisPlus laser is indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes, Trichophyton rubrum and T. mentagrophytes, and/or yeast Candida Albicans, etc.).
Performance Data: None
Results of Clinical Study: None
Summary of Technological Characteristics:
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Attachment 5 510(K) Summary Cutera GenesisPlus Laser System
| Features | Cutera Genesis Plus Laser | PinPointe FootlaserK09354, K083545 | Cutera Nd:YAG LaserK022226 |
|---|---|---|---|
| Wavelength | 1064nm Nd:YAG | 1064nm Nd:YAG | 1064nm Nd:YAG |
| Aiming Beam | 630-680nm(≤ 2.5mW) | 630-680nm(≤ 2.5mW) | none |
| Energy per Pulse | 20-3500 mJ | 20 - 3500 mJ | ≤ 3500mJ |
| Fluence | 25.5 J/cm2 (with 1mmspot) | 25.5 J/cm2 (with1mm spot) | Up to 25,000J/cm2 (with0.1mm spot) |
| Max Power | ≤ 100W | ≤100W | ≤100W |
| Pulse Duration | 100 - 3000μs | 100 - 3000 μs | ≤ 300ms |
| Spot Size | 1 mm (for Podiatry)Up to 13mm (otherindications) | 1mm (for podiatry)Other spot sizesare not published | 0.1 - 13mm |
| Output mode | Pulsed | Pulsed, multimode | Pulsed |
| Repetition Rate | 5 - 100 Hz | 5 - 100 Hz | Single shot and up to 10Hz |
| Laser Media | Flashlamp pumpedsolid state rod | Flashlamp pumpedsolid state laser rod | Flashlamp pumped solidstate rod |
| User Interface | LCD colortouchscreen | LCD color touchscreen or push-button controlpanel | Push button control orLCD color touchscreen |
Conclusion:
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ﺍﻟﻌﻤﻞ ﺍﻟﻤﻨﺘﺪﻯ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺎﺑﻘﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘ
.. .. .. ..
The Culera GenesisPlus Laser is substantially equivalent to the Cutera Nd:YAG Laser (K022226) and to the PinPointe Footlaser (K09354 and K083545). The Cutera GenesisPlus Laser is substantially equivalent in terms of indication for use and technology based on technical characteristics.
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Image /page/3/Picture/1 description: The image contains the words "Public Health Service" in a bold, sans-serif font. The text is arranged on a single line, with each word clearly legible. The overall impression is clean and straightforward, suggesting an official or institutional context.
May 13, 2013
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Cutera, Inc. % Ms. Connie Hoy 3240 Bayshore Boulevard Brisbane, California 94005
Re: K103626
Trade/Device Name: Cutera GenesisPlus Laser System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: PDZ, GEX Dated: March 24, 2011 Received: March 25, 2011
Dear Ms. Hoy:
This letter corrects our substantially equivalent letter of April 5, 2011.
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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
Image /page/3/Picture/11 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the upper half of the circle.
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Page 2 - Ms. Connie Hoy
comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801; medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.hum.
Sincerely yours, FOR
Peter D. Rumm Brokers Comment Hackback of the Production of the Production
Company of Children D Each Personal Production
Company Company Desemble Comparis C 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 -2
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
K 103626 510(k) Number (if known):
Device Name : Cutera GenesisPlus Laser System
Indications for Use:
The Cutera GenesisPlus Nd:YAG laser is intended for use in the medical specialties of general and plastic surgery, dermatology, endoscopic.laproscopic general surgery, gastroenterology, gynecology, otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, pulmonary.thoracic surgery, podiatry and urology for surgical and aesthetic applications.
Dermatology:
.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
:
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Specifical propositions of the proposition of the first of the first of the first of the first of the first of the first of the first of the first of the first of the first o
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The Cutera GenesisPlus laser is intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, rosacea, poikiloderma of civatte,, and treatment of benign cutaneous lesions, such as warts, scars and straie. The laser is also intended for the treatment of benign pigmented lesions.
The Cutera GenesisPlus laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles.
The GenesisPlus laser is indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin,
Podiatry:
Podiatry (ablation, vaporization, incision, excision, and coagulation of soft tissue) including:
- Matrixectomy .
- . Periungual and subungual warts
- Plantar warts .
- Radical nail excision .
- Neuromas .
The Cutera GenesisPlus laser is indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophyton rubrum and T. mentagrophytes, and/or yeast Candida Albicans, etc.).
Prescription Use XX (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) on of m
Division Sigh Division of Surgical. Orthopedic, and Restorative Devices
Page 1 of 1
510(k) Number K103626
§ 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.