(227 days)
Not Found
No
The summary describes a laser system with different wavelengths and pulse widths for tattoo removal. There is no mention of AI, ML, image processing, or any other technology that would suggest the use of AI/ML for analysis, treatment planning, or any other function. The performance studies focus on the clinical efficacy of the laser parameters.
Yes
The document states that the device is "intended for use in surgical and aesthetic applications" and "is indicated for tattoo removal". Tattoo removal, especially when performed with laser systems by medical professionals, can be considered a therapeutic procedure aimed at treating a physical condition (unwanted tattoos) for medical or aesthetic reasons.
No
The device description and intended use clearly state that the enlighten laser system is designed for "surgical and aesthetic applications" and specifically for "tattoo removal." There is no mention of it being used to diagnose any condition or disease.
No
The device description clearly outlines a physical laser system with hardware components including a console, power supplies, control electronics, touchscreen, footswitch, articulated arm, handpiece, and detachable tips. It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery" and specifically mentions "tattoo removal." This describes a therapeutic or aesthetic procedure performed directly on a patient's body.
- Device Description: The description details a laser system designed to deliver energy to the skin for tattoo removal. This is an external, non-invasive or minimally invasive treatment device.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of biological specimens.
The information provided describes a medical device used for a therapeutic/aesthetic procedure, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The enlighten laser system is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery.
1064 nm
The 1064 nm wavelength of the enlighten laser system is indicated for tattoo removal for dark colored tattoo inks and for multicolored tattoos containing dark colored tattoo inks on patients with all skin types (Fitzpatrick I-VI).
532 nm
The 532 nm wavelength of the enlighten laser system is indicated for tattoo removal for lighter colored tattoo inks, including red and yellow inks, on patients with Fitzpatrick skin types I-III.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The enlighten laser system is a multi-wavelength, pulsed laser system designed for tattoo removal. A key feature of the device is its ability to produce multiple laser wavelengths (1064 nm and 532 nm) and pulse widths (750 ps and 2 ns, nominal). The laser, power supplies and control electronics are housed inside a console equipped with a touchscreen control panel. The laser treatment parameters are selected using the control panel. Laser emission is activated by depressing a footswitch. The system is operated using 110 V mains AC power.
An articulated arm with rotational mirror knuckles delivers the laser beam from a laser head inside the console to a handpiece. The handpiece is equipped with a detachable tip that determines the spot size of the laser beam on the treatment surface. Multiple tips are provided to vary the spot size as desired for treatment. The beam of a low-power red diode laser is also transmitted through the arm to provide an aiming beam.
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)
An IRB-approved multicenter prospective clinical study was conducted to assess the safety and efficacy of the enlighten laser system for tattoo removal. Forty-two subject tattoos of black/blue ink, alone or with other colors, older than one year and 2 to 12 square inches in size were enrolled. Forty-one subject tattoos completed the study with 1 lost to follow-up. Subject tattoos were divided into 2 portions for treatment with the Cutera Investigational Q-Switched Nd:YAG laser and a comparator Q-switched Nd:YAG laser respectively, based on randomization assignment. Subject tattoos received 2 to 3 treatments with both laser systems performed 6 weeks apart. Subject tattoos were followed for 6 weeks following final laser treatment.
Standardized photographs were taken at baseline and 6 weeks following the final treatment. Primary efficacy assessments were performed through review of tattoo photographs taken at baseline and 6 weeks post-final treatment by a panel of independent, blinded reviewers (dermatologists). Safety was assessed by the investigator at each visit and via phone surveys (subject reporting) conducted at 3 and 14 days following each laser treatment.
Blinded review of baseline and post-treatment tattoo photographs resulted in a clinically and statistically significant mean improvement of 2.54 (95% CI: 2.13–2.94) and 2.17 (95% CI: 1.77–2.57) for the Cutera Investigational device and comparator device, respectively, a 6 weeks post-final treatment. The mean difference in reviewer's global assessment of improvement scores between the Investigational and comparator devices was 0.37 (95% CI: 0.20–0.53), indicating that the Investigational device resulted in more clearing than the comparator device at 6 weeks following 2 to 3 treatment sessions. This result was statistically significant (p
§ 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
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is simple and clean, and it is easily recognizable.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 6, 2014
Cutera Incorporated Mr. Bradley Renton Vice President, Regulatory and Medical Affairs 3240 Bayshore Boulevard Brisbane, California 94005
Re: K140727
Trade/Device Name: enlighten 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: October 28, 2014 Received: October 29, 2014
Dear Mr. Renton:
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
1
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 Industry and Consumer Education 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. 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 Industry and Consumer Education 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.htm.
for
Sincerely yours,
David Krause -S
- Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Section 4 Indications for Use
510(k) Number (if known): K140727
Device Name: enlighten Laser System
Indications for Use:
The enlighten laser system is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery.
1064 nm
The 1064 nm wavelength of the enlighten laser system is indicated for tattoo removal for dark colored tattoo inks and for multicolored tattoos containing dark colored tattoo inks on patients with all skin types (Fitzpatrick I-VI).
532 nm
The 532 nm wavelength of the enlighten laser system is indicated for tattoo removal for lighter colored tattoo inks, including red and yellow inks, on patients with Fitzpatrick skin types I-III.
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)
3
Section 5 510(K) Summary
This 510(K) Summary of safety and effectiveness for the enlighten 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: | Bradley Renton |
| Telephone: | 415-657-5568 - phone |
| Fax: | 415-715-3568 - fax |
| Email: | brenton@cutera.com |
| Preparation Date: | October 21, 2014 |
| Device Trade Name: | enlighten Laser System |
| Common Name: | Dermatology Laser |
| Classification Name: | Instrument, Surgical, Powered, laser |
| 79-GEX, 21 CFR 878.4810 | |
| Legally Marketed | |
| Predicate Devices: | Cutera Q-Switch Laser System (K102954) |
| Quanta System Q-Plus T (K073549) | |
| Cynosure PicoSure (K121346) | |
| Device Description: | The enlighten laser system is a multi-wavelength, pulsed laser |
| system designed for tattoo removal. A key feature of the device is | |
| its ability to produce multiple laser wavelengths (1064 nm and 532 | |
| nm) and pulse widths (750 ps and 2 ns, nominal). The laser, power | |
| supplies and control electronics are housed inside a console | |
| equipped with a touchscreen control panel. The laser treatment | |
| parameters are selected using the control panel. Laser emission is | |
| activated by depressing a footswitch. The system is operated using | |
| 110 V mains AC power. |
An articulated arm with rotational mirror knuckles delivers the laser
beam from a laser head inside the console to a handpiece. The
handpiece is equipped with a detachable tip that determines the
spot size of the laser beam on the treatment surface. Multiple tips
are provided to vary the spot size as desired for treatment. The
beam of a low-power red diode laser is also transmitted through the
arm to provide an aiming beam. |
| Intended Use: | The enlighten laser system is intended for use in surgical and
aesthetic applications in the medical specialties of dermatology and
general and plastic surgery. |
| Specific Indications: | 1064 nm:
The 1064 nm wavelength of the enlighten laser system is indicated
for tattoo removal for dark colored tattoo inks and for multicolored
tattoos containing dark colored tattoo inks on patients with all skin
types (Fitzpatrick I-VI). |
| | 532 nm:
The 532 nm wavelength of the enlighten laser system is indicated
for tattoo removal for lighter colored tattoo inks, including red and
yellow inks, on patients with Fitzpatrick skin types I-III. |
| Performance Data: | IEC 60601-1 Medical Electrical Equipment - Part 1: General
Requirements for Safety |
| | IEC 60601-1-2 Medical Electrical Equipment – Part 1-2: General
Requirements for Safety - Collateral Standard: Electromagnetic
Compatibility |
| | Nova Software Verification and Validation Testing Report
(V0083 r1) |
| Results of Clinical
Study: | An IRB-approved multicenter prospective clinical study was
conducted to assess the safety and efficacy of the enlighten laser
system for tattoo removal. Forty-two subject tattoos of black/blue
ink, alone or with other colors, older than one year and 2 to 12
square inches in size were enrolled. Forty-one subject tattoos
completed the study with 1 lost to follow-up. Subject tattoos were
divided into 2 portions for treatment with the Cutera Investigational
Q-Switched Nd:YAG laser and a comparator Q-switched Nd:YAG
laser respectively, based on randomization assignment. Subject
tattoos received 2 to 3 treatments with both laser systems
performed 6 weeks apart. Subject tattoos were followed for 6 weeks
following final laser treatment. |
| | Standardized photographs were taken at baseline and 6 weeks
following the final treatment. Primary efficacy assessments were
performed through review of tattoo photographs taken at baseline
and 6 weeks post-final treatment by a panel of independent, blinded
reviewers (dermatologists). Safety was assessed by the investigator
at each visit and via phone surveys (subject reporting) conducted at
3 and 14 days following each laser treatment. |
| | Blinded review of baseline and post-treatment tattoo photographs
resulted in a clinically and statistically significant mean improvement
of 2.54 (95% CI: 2.13–2.94) and 2.17 (95% CI: 1.77–2.57) for the
Cutera Investigational device and comparator device, respectively, a
6 weeks post-final treatment. The mean difference in reviewer's
global assessment of improvement scores between the
Investigational and comparator devices was 0.37 (95% CI: 0.20–
0.53), indicating that the Investigational device resulted in more
clearing than the comparator device at 6 weeks following 2 to 3 |
4
5
Attachment 5 510(K) Summary
treatment sessions. This result was statistically significant (p