(116 days)
K09354 and K093545, K0222226
Not Found
No
The document describes a laser device with standard controls and delivery mechanisms, and there is no mention of AI or ML in the intended use, device description, or any other section.
Yes
The device is intended for various medical procedures, including coagulation, hemostasis, treatment of wrinkles, and soft tissue procedures in different medical specialties, all of which aim to treat or alleviate diseases/conditions or affect the structure/function of the body.
No
The device description and intended use clearly state that the Cutera GenesisPlus Nd:YAG laser is an energy delivery device used for surgical and aesthetic applications (e.g., coagulation, hemostasis, ablation, vaporization, incision, excision). These are therapeutic procedures, not diagnostic ones.
No
The device description clearly states it is a "Laser unit and controls are contained in a single console" and delivers energy via a "handpiece using a fiber optic delivery system." This indicates a physical hardware device that emits laser energy, not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Cutera GenesisPlus Function: The description clearly states the Cutera GenesisPlus is a laser device that delivers energy to tissue for surgical and aesthetic applications. It directly interacts with the patient's body.
- Intended Use: The intended uses listed are all procedures performed directly on the patient (coagulation, hemostasis, treatment of wrinkles, ablation, vaporization, etc.).
- Device Description: The description details a laser unit, handpiece, fiber optic delivery system, and footswitch – all components for delivering energy to the body, not for analyzing samples.
The Cutera GenesisPlus is a therapeutic and surgical device, not a diagnostic one that analyzes samples outside the body.
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.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, 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.).
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)
Performance Data: None
Results of Clinical Study: None
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.
K09354 and K093545, K0222226
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 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:
ட்டிட்ட போட்டி
..............................................................................................................................................................................
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.
1
Attachment 5 510(K) Summary Cutera GenesisPlus Laser System
Specific Indications:
.. ﺃﻧﻪ ... :: :: : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : :
్లో
....
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:
2
Attachment 5 510(K) Summary Cutera GenesisPlus Laser System
| Features | Cutera Genesis Plus Laser | PinPointe Footlaser
K09354, K083545 | Cutera Nd:YAG Laser
K022226 |
|------------------|----------------------------------------------------------|---------------------------------------------------------------|-------------------------------------------------|
| 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 1mm
spot) | 25.5 J/cm2 (with
1mm spot) | Up to 25,000J/cm2 (with
0.1mm spot) |
| Max Power | ≤ 100W | ≤100W | ≤100W |
| Pulse Duration | 100 - 3000μs | 100 - 3000 μs | ≤ 300ms |
| Spot Size | 1 mm (for Podiatry)
Up to 13mm (other
indications) | 1mm (for podiatry)
Other spot sizes
are not published | 0.1 - 13mm |
| Output mode | Pulsed | Pulsed, multimode | Pulsed |
| Repetition Rate | 5 - 100 Hz | 5 - 100 Hz | Single shot and up to 10
Hz |
| Laser Media | Flashlamp pumped
solid state rod | Flashlamp pumped
solid state laser rod | Flashlamp pumped solid
state rod |
| User Interface | LCD color
touchscreen | LCD color touch
screen or push-
button control
panel | Push button control or
LCD color touchscreen |
Conclusion:
தியாக விட்ட விட்ட பாட்டக்காவிக்கு
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.
3
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.
4
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
5
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:
.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
:
・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・
::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::
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
i
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