(272 days)
Not Found
No
The document describes a laser device with a fiber optic delivery system and footswitch activation, with no mention of AI or ML capabilities.
Yes
The device is described as being used for the "coagulation and hemostasis of benign vascular lesions," "treatment of wrinkles," and "temporary increase of clear nail in patients with onychomycosis," which are all therapeutic interventions.
No
The device description and intended use indicate it is a laser for surgical and aesthetic applications, such as coagulation, hemostasis, and ablation, not for diagnosing medical conditions.
No
The device description clearly states it is a laser unit with a console, handpiece, fiber optic delivery system, and footswitch, indicating it is a hardware-based medical device.
Based on the provided text, the Cutera GenesisPlus Nd.YAG laser is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens from the human body (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
- The description of the Cutera GenesisPlus clearly states it is a laser used for surgical and aesthetic applications directly on the patient's body. It delivers laser energy to tissue for procedures like coagulation, hemostasis, ablation, and treatment of various conditions.
The intended use and device description focus on direct interaction with the patient's body, not on analyzing samples in a laboratory setting.
N/A
Intended Use / Indications for Use
The Cutera GenesisPlus Nd:YAG laser is intended for use in the medical specialties of general and plastic surgery, dermatology, endoscopic/laparoscopic general surgery, gastroenterology, gynecology, otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, pulmonary/thoracic surgery, podiatry and urology for surgical and aesthetic applications.
Specific Indications:
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.).
Product codes (comma separated list FDA assigned to the subject device)
PDZ, GEX
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
A clinical study was conducted to evidence that the change to the treatment parameters for the podiatry indication is safe and effective. The study demonstrated safety and effectiveness for use for the temporary increase of clear nail.
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
Attachment 6 510(K) Summary Cutera GenesisPlus Laser System
MAY 1 5 2013
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 fide case guidance concerning the organization and content of a 510(K) summany
| Applicant: | Cutera, Inc. |
|---|---|
| Address: | 3240 Bayshore Blvd. |
| Brisbane, CA 94005 | |
| Contact Person: | Connie Hoy |
| Telephone: | |
| Fax: | |
| Email: | 415-657-5592 - phone |
| 415-715-3592 - fax | |
| choy@cutera,com | |
| Preparation Date: | August 10, 2012 |
| Device Trade Name: | Cutera GenesisPlus Laser System |
| Common Name: | Nd:YAG Laser |
| Classification Name: | Instrument, Surgical, Powered, laser |
| 79-GEX, 21 CFR 878-48 | |
| Legally | |
| Marketed | |
| Predicate | |
| Device: | Cutera GenesisPlus under K103626 |
| 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. |
1
Attachment 6 510(K) Summarv Cutera GenesisPlus Laser System
Specific Indications:
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:
A clinical study was conducted to evidence that the change to the treatment parameters for the podiatry indication is safe and effective. The study demonstrated safety and effectiveness for use for the temporary increase of clear nail.
Summary of Technological Characteristics:
2
Attachment 6 510(K) Summary Cutera GenesisPlus Laser System
| Features | Cutera GenesisPlus Laser
(K)103626) | Cutera GenesisPlus Laser
(revised) |
|------------------|----------------------------------------|---------------------------------------|
| Wavelength | 1064nm Nd:YAG | 1064nm Nd:YAG |
| Aiming Beam | 630-680nm
(≤ 2.5mW) | 630-680nm
(≤ 2.5mW) |
| Energy per Pulse | 20-3500 mJ | 20-3500 mJ |
| Fluence | 25.5J/cm2 (with 1mm spot) | 25.5J/cm2 (with 1mm spot) |
| Power | ≤ 100W | ≤ 100W |
| Spot Size | Up to 13mm | Up to 13mm |
| Pulse Duration | 100-3000μs | 100-3000μs |
| Output mode | Pulsed | Pulsed |
| Repetition Rate | 5-100 Hz | 5-100 Hz |
| Laser Media | Flashlamp pumped solid state rod | Flashlamp pumped solid state rod |
| User Interface | LCD color touchscreen | LCD color touchscreen |
Comparison of Technical Specification for Dermatology indications for use:
Comparison of Technical Specification for temporary increase of clear nail indication for use: .
| Features | Cutera GenesisPlus Laser
(K)103626) | Cutera GenesisPlus Laser
(revised) |
|------------------------------------|----------------------------------------|---------------------------------------|
| Wavelength | 1064nm Nd:YAG | 1064nm Nd:YAG |
| Aiming Beam | 630-680nm
(≤ 2.5mW) | 630-680nm
(≤ 2.5mW) |
| Fluence | 25.5J/cm2 (with 1mm spot) | 15-18 J/cm2 |
| Power | ≤ 100W | ≤ 100W |
| Spot Size | 1.0-1.5mm | 5mm |
| Pulse Duration | 100μs | 0.3ms |
| Output mode | Pulsed | Pulsed |
| Repetition Rate | 20 Hz | 2-3Hz |
| Burst Mode
Sequence | ½ second on
½ second off | Not applicable |
| Laser Media | Flashlamp pumped solid state rod | Flashlamp pumped solid state rod |
| User Interface | LCD color touchscreen | LCD color touchscreen |
| Laser activation | Footswitch | Footswitch |
| Delivery Devices
(How Supplied) | Non-sterile, reusable, cleanable | Non-sterile, reusable, cleanable |
Conclusion:
The Cutera GenesisPlus Laser is substantially equivalent to the previously cleared Cutera GenesisPlus Laser (K103626). The Cutera GenesisPlus Laser is substantially equivalent in terms of indication for use and technology based on technical characteristics.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of an abstract human figure with three flowing lines extending from its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the graphic.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
May 15, 2013
Cutera, Inc. % Ms. Connie Hoy 3240 Bayshore Boulevard Brisbane, California 94005
Re: K122493
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: April 22, 2013 Received: April 23, 2013
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. 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 comply with all the Act's requirements, including, but not limited to: registration and listing (21
4
Page 2 - Ms. Connie Hoy
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 (OS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Industrv/default.htm.
Sincerely yours,
FOR
Peter D. Rúmm -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known):___ K 122493
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.laproscopic.label specialites of general otorhinolaryngology (ENT), neurosurgery, oculoplastics, pulmonary.hnoracis surgery, podiaty and urology for surgical and aesthetic applications.
Dermatology:
The Cutera GenesisPlus faser is intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, rosaceal 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., dermatophyton rubrum and T. mentagrophytes, and/or yeast Condida 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)
Neil R Ogden 2013.05.09 15:16:48 -04'00' Page 1 of 1
(Division Sign-Off) for MXM Division of Surgical Devices 510(k) Number_________________________________________________________________________________________________________________________________________________________________