(260 days)
Not Found
No
The summary describes a laser device with specific wavelengths and pulse durations for dermatological procedures. There is no mention of AI, ML, image processing, or any data-driven decision-making components.
Yes
The device is described as a laser system for various dermatological procedures, including incision, excision, ablation, coagulation, treatment of lesions and scars, and tattoo removal, all of which are considered therapeutic interventions.
No
The device description and intended use clearly state that this is a laser system designed for therapeutic procedures like incision, excision, ablation, vaporization, and removal/reduction of various skin conditions. It delivers laser energy to tissue to create a clinical effect, rather than to diagnose conditions.
No
The device description explicitly details a physical laser unit, console, articulated arm, handpiece, and footswitch, indicating it is a hardware device that delivers 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 such as blood, urine, or tissue that have been taken from the human body to detect diseases, conditions, or infections.
- Device Function: The description clearly states that this device is a laser system used for surgical procedures on soft tissue and skin. It delivers laser energy directly to the tissue for incision, excision, ablation, vaporization, coagulation, and hemostasis.
- Lack of Sample Analysis: There is no mention of the device analyzing samples taken from the body. Its function is to interact directly with the patient's tissue.
- Intended Use/Indications: The listed indications are all related to treating conditions or performing procedures directly on the patient's skin and soft tissue (tattoo removal, lesion removal, scar reduction, etc.).
Therefore, this device falls under the category of a surgical laser or dermatological laser, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
General: Incision, Excision, Ablation and Vaporization of Soft Tissue for General Dermatology, Dermatologic and General Surgical Procedures for Coagulation and Hemostasis.
Specific: For use for the following indications: Treatment of Epidermal Pigmented Lesions, Treatment of Dermal Pigmented Lesions, Nevus of Ota, Laser skin resurfacing procedures for the treatment of acne scars and wrinkles, Tattoo Removal, Treatment of Vascular Lesions, Removal or lightening of unwanted hair and treatment of Benign Cutaneous Lesions.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The Cutera QSwitch 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 an articulated arm and a specially designed Multiple Spot Handpiece (532 nm and 1064 nm). The user activates laser emission by means of a footswitch.
The Cutera QSwitch Laser is designed to provide laser energy for use in a variety of dermatological procedures. The 532 nm and 1064 nm wavelengths are absorbed by pigment and other chromophores within the skin to create the desired clinical effect.
The laser incorporates very narrow laser pulses (5-20 ns) designed to apply higher peak power over a very short period to minimize the time to absorb heat into the tissue.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft Tissue, Epidermal, Dermal, Skin, Hair
Specific treatments listed for: acne scars, wrinkles, Nevus of Ota, tattoos, vascular lesions, benign cutaneous lesions, striae, scars, port wine birthmarks, telangjectasias, spider angioma, cherry angioma, spider nevi, cafe-au-lait birthmarks, solar lentiginos, senile lentiginos, Becker's nevi, freckles, nevus spilus, hypertrophic and keloid scars.
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.
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
K102954 pg 1 of 3
..
Attachment 5 510(K) Summary Cutera QSwitch Laser System
JUN 2 2 2011
This 510(K) Summary of safety and effectiveness for the Cutera QSwitch Laser System 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: | 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: | October 4, 2010 |
| Device Trade Name: | Cutera QSwitch Laser System |
| Common Name: | Nd:YAG Laser |
| Classification Name: | Instrument, Surgical, Powered, laser |
| 79-GEX, 21 CFR 878-48 | |
| Legally Marketed Predicate | |
| Device: | RevLite Q-Switched Nd:YAG Laser System |
| K083899 | |
| Description of the Cutera | |
| QSwitch Laser System: | The Cutera QSwitch Laser unit and controls are contained |
| in a singleconsole. 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 an articulated arm and a specially designed | |
| Multiple Spot Handpiece (532 nm and 1064 nm). The user | |
| activates laser emission by means of a footswitch. | |
| The Cutera QSwitch Laser is designed to provide laser | |
| energy for use in a variety of dermatological procedures. | |
| The 532 nm and 1064 nm wavelengths are absorbed by | |
| pigment and other chromophores within the skin to create | |
| the desired clinical effect. | |
| The laser incorporates very narrow laser pulses (5-20 ns) | |
| designed to apply higher peak power over a very short | |
| period to minimize the time to absorb heat into the tissue. |
1
102954 pg 2 of 3
Attachment 5 510(K) Summary Cutera QSwitch Laser System
Intended use of the Cutera QSwitch Laser System:
General: Incision, Excision, Ablation and Vaporization of Soft Tissue for General Dermatology, Dermatologic and General Surgical Procedures for Coagulation and Hemostasis.
Specific: For use for the following indications: Treatment of Epidermal Pigmented Lesions, Treatment of Dermal Pigmented Lesions, Nevus of Ota, Laser skin resurfacing procedures for the treatment of acne scars and wrinkles, Tattoo Removal, Treatment of Vascular Lesions, Removal or lightening of unwanted hair and treatment of Benign Cutaneous Lesions.
Performance Data: None
Results of Clinical Study: None
Summary of Technological Characteristics:
| Cutera, Inc. Q-Switched Laser | RevLite Q-Switched Nd:YAG Laser | |
|---|---|---|
| Wavelength | 532nm | 532nm |
| Max delivered Energy @end of articulate arm with no handpiece | 500mJ | 500mJ |
| Spot Size | 2mm -6mm | 2mm -6mm |
| Maximum Fluence @ 2mm spot | 5J/cm2 | 5J/cm2 |
| Maximum Fluence @ 6mm spot | 1.5J/cm2 | unknown |
| Pulse Width | 5-20ns | 5-20ns |
| Rep Rate | Single shot, 1,2,5 and 10 pulses per second (Hertz) | Single shot, 1,2,5 and 10 pulses per second (Hertz) |
| Wavelength | 1064nm | 1064nm |
| Max delivered Energy @end of articulate arm with no handpiece | 1.6J | 1.6J |
| Spot Size | 3mm -8mm | 3mm -8mm |
| Maximum Fluence @ 3mm spot | 12J/cm2 | 12J/cm2 |
| Maximum Fluence @ 8mm spot | 3.5J/cm2 | unknown |
| Pulse Width | 5-20ns | 5-20ns |
| Rep Rate | Single shot, 1,2,5 and 10 pulses per second (Hertz) | Single shot, 1,2,5 and 10 pulses per second (Hertz) |
2
K102954 pg. 3 of 3
Attachment 5 510(K) Summary Cutera QSwitch Laser System
Conclusion:
The Cutera QSwitch Laser System is substantially equivalent to the RevLite QSwitch Nd:YAG Laser. (K083899). The Cutera QSwitch Laser is system substantially equivalent in terms of indication for use and technology based on technical characteristics.
3
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUN 2 2 2011
Cutera, Inc. % Ms. Connie Hoy 3240 Bayshore Boulevard Brisbane, California 94005
Re: K102954
Trade/Device Name: Cutera QSwitch 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: GEX Dated: May 26, 2011 Received: May 31, 2011
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
4
Page 2 - Ms. Connie Hoy
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); 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 go to http://www.fda.gov/AboutFDA/CentersQffices/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
pg 1 of 1
510(k) Number (if known): (K)102954
Device Name : Cutera QSwitch Laser System
Intended Use: Incision, Excision, Ablation, Vaporization of Soft Tissue for General Dermatology, Dermatologic and General Surgical Procedures for Coagulation and Hemostasis.
Indications for Use:
1064 nm wavelength
- Tattoo Removal (dark ink: blue and black) .
- Nevus of Ota ●
- Removal or lightening of hair with or without adjuvant preparation. .
- Skin Resurfacing for Acne Scars and Wrinkles ●
- Benign cutaneous lesions, such as, but not limited to: striae and scars
- Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an . integral part of the scar
532 nm wavelength
- Tattoo removal (light ink: red, sky blue, green) .
- Vascular lesions including but not limited to: port wine birthmarks, telangjectasias, �
- spider angioma, cherry angioma, spider nevi .
- Epidermal Piamented lesions including but not limited to: cafe-au-lait birthmarks, . solar lentiginos, senile lentiginos, Becker's nevi, Freckles, Nevus spilus
- Skin Resurfacing for Acne Scars and Wrinkles .
- Benign cutaneous lesions, such as, but not limited to: striae and scars .
- Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an . integral part of the scar
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)
Page 1 of 1 forman
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K102954