(26 days)
The enlighten III 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 III laser system is indicated for:
- treatment of benign pigmented lesions on patients with all skin types (Fitzpatrick I-VI)
- 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 III laser system is indicated for:
- treatment of benign pigmented lesions on patients with Fitzpatrick skin types I-III
- tattoo removal for lighter colored tattoo inks, including red and yellow inks, on patients with Fitzpatrick skin types I-III
670 nm:
The 670 nm wavelength of the enlighten III laser system is indicated for treatment of benign pigments with Fitzpatrick skin types I-III.
The modified Cutera enlighten III laser system is a multi-wavelength, pulsed laser system. A key feature of the device is its ability to produce multiple laser wavelengths and pulse widths (1064 and 532 nm: 750 ps and 2 ns; 670 nm: 660 ps and 2 ns).
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. 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 an optical zoom assembly that determines the spot size of the laser beam on the treatment surface. The beam of a low-power diode laser is also transmitted through the arm to provide an aiming beam.
This document is an FDA 510(k) premarket notification for a modification to the Cutera enlighten III Laser System. It focuses on demonstrating substantial equivalence to a previously cleared device. Therefore, it does not contain the kind of detailed study data (like sample sizes, expert qualifications, or comparative effectiveness with human readers) that would be present in a clinical trial report for a new device.
Here's an analysis of what is and isn't provided based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" for clinical performance. Instead, it details modifications to the device's operational parameters and then asserts that these modifications do not introduce new risks or change the intended use, implying that the device, with these modifications, still meets the safety and effectiveness profile of its predicate.
However, the key performance data discussed relates to the device's technical specifications and compliance with safety standards.
| Acceptance Criteria (Implied / Stated Compliance) | Reported Device Performance (with modifications) |
|---|---|
| Safety and Electrical Standards Compliance | Complies with: - IEC 60601-1 (Edition 3.1, 2012) - IEC 60601-1-6 (Edition 3.1, 2013) - IEC 62366 (Edition 1.1, 2014) - IEC 60601-2-22 (Edition 3.1, 2012) - IEC 60825-1 (Edition 2.0, 2007) - AAMI/ANSI ES60601-1:2005+A2 (R2012)+A1 - IEC 60601-1-2 (Edition 3, 2007) |
| Maximum Delivered Energy | 1064 nm: Increased from 600 mJ to 800 mJ (maintaining 10 J/cm² max fluence) 532 nm: Increased from 300 mJ to 400 mJ (maintaining 2.5 J/cm² max fluence) |
| Maximum Treatment Fluence | 1064 nm: Maintained at 10 J/cm² 532 nm: Maintained at 2.5 J/cm² |
| Spot Sizes | Added 9 mm and 10 mm incremental spot sizes for 1064 nm and 532 nm wavelengths. |
| Pulse Duration | Added 2 ns pulse duration for the 670 nm wavelength. |
| No New Risks Introduced | Affirmed based on unchanged maximum treatment fluence and no changes to intended use or indications for use. |
| Equivalence in Intended Use/Indications | Identical to predicate device. |
| Equivalence in Technical Specifications | Similar or within range of predicate and reference devices in spot sizes, wavelengths, pulse widths, laser types, and repetition rates. |
| Equivalence in Operating Performance | Similar to predicate and reference devices. |
| Equivalence in General Design | Similar to predicate and reference devices. |
2. Sample size used for the test set and data provenance
The document refers to a "Performance Data: enlighten III Software Verification and Validation Testing Report (V0140 rA1)". This report likely contains the details of the test set and data provenance for the software modifications. However, the FDA letter does not provide any specific sample sizes or data provenance (e.g., country of origin, retrospective/prospective) for clinical or performance data related to the device's efficacy in treating patients.
The "testing" mentioned primarily concerns software verification and validation and compliance with electrical and safety standards, not a clinical study on human subjects with a "test set" in the context of diagnostic accuracy.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. As this is a 510(k) for a laser system modification, the "ground truth" would likely refer to the physical output parameters of the laser, verified by engineering and metrology, rather than expert clinical consensus on patient outcomes, which is typical for AI diagnostic devices.
4. Adjudication method for the test set
This information is not provided. Given the nature of the device (a laser system for treatment), "adjudication method" in the context of reconciling expert opinions (as described by "2+1, 3+1") is not relevant here. The "testing" pertains to engineering standards and device performance specifications.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No, an MRMC comparative effectiveness study was not done or described in this document. This type of study is relevant for evaluating the impact of AI algorithms on human reader performance, typically in diagnostic imaging, which is not the function of this laser system.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This concept is not applicable to this device. The Cutera enlighten III is a physical laser system, not a diagnostic algorithm. The "algorithm" here refers to the control software that dictates the laser's operational parameters, and its "performance" is judged by its ability to control the hardware within specified tolerances and safety limits.
7. The type of ground truth used
The implicit "ground truth" for this device's performance is its technical specifications and adherence to international safety and electrical standards (e.g., IEC 60601-1, IEC 60825-1, etc.), as well as the accurate output of laser parameters (energy, fluence, spot size, pulse duration). This is established through engineering measurements and metrology, not pathology, outcomes data, or expert clinical consensus on patient diagnosis.
8. The sample size for the training set
This information is not applicable and therefore not provided. The device's "software modification" does not involve machine learning or AI models that require a "training set" in the typical sense of classifying data or predicting outcomes. The software is a set of control logic and algorithms to operate the laser system.
9. How the ground truth for the training set was established
This information is not applicable for the same reasons as #8.
{0}------------------------------------------------
Image /page/0/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of three stylized human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 25, 2017
Cutera, Inc. Dr. Bradley Renton Vice President. Regulatory and Medical Affairs, & Compliance Officer 3240 Bayshore Blvd. Brisbane, California 94005
Re: K170936
Trade/Device Name: Cutera enlighten III 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: March 29, 2017 Received: March 30, 2017
Dear Dr. Bradley 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 CFR
{1}------------------------------------------------
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
Sincerely, Jennifer R. Stevenson -For 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}------------------------------------------------
Indications for Use
510(k) Number (if known) K170936
Device Name Cutera enlighten III Laser System
Indications for Use (Describe)
The enlighten III 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 III laser system is indicated for:
- · treatment of benign pigmented lesions on patients with all skin types (Fitzpatrick I-VI)
• 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 III laser system is indicated for:
- · treatment of benign pigmented lesions on patients with Fitzpatrick skin types I-III
- tattoo removal for lighter colored tattoo inks, including red and yellow inks, on patients with Fitzpatrick skin types I-III
670 nm:
The 670 nm wavelength of the enlighten III laser system is indicated for treatment of benign pigments with Fitzpatrick skin types I-III.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | ☑ |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) | ☐ |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
Section 5 Special 510(K) Summary – Device Modification
This 510(K) Summary of safety and effectiveness for the modified Cutera enlighten III 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 |
| 415-657-5568 — phone415-715-3568 – faxbrenton@cutera.com | |
| Preparation Date: | April 19, 2017 |
| Device Trade Name: | Cutera enlighten III Laser System |
| Common Name: | Dermatology Laser |
| Classification Name: | Instrument, Surgical, Powered, laser79-GEX, 21 CFR 878.4810 |
| Legally MarketedPredicate Devices: | Cutera enlighten III Laser System (K160488) |
| Legally MarketedReference Devices: | Quanta Systems SpA, Discovery Pico Family (K163222)Cynosure, RevLite (K133254) |
| Device Description: | The modified Cutera enlighten III laser system is a multi-wavelength, pulsed laser system. A key feature of the device is itsability to produce multiple laser wavelengths and pulse widths(1064 and 532 nm: 750 ps and 2 ns; 670 nm: 660 ps and 2 ns). |
| The laser, power supplies, and control electronics are housedinside a console equipped with a touchscreen control panel. Thelaser treatment parameters are selected using the control panel.Laser emission is activated by depressing a footswitch. Anarticulated arm with rotational mirror knuckles delivers the laserbeam from a laser head inside the console to a handpiece. Thehandpiece is equipped with an optical zoom assembly thatdetermines the spot size of the laser beam on the treatmentsurface. The beam of a low-power diode laser is also transmittedthrough the arm to provide an aiming beam. | |
| Indications for Use: | 1064 nm |
| The 1064 nm wavelength of the Cutera enlighten III laser system isindicated for: |
- treatment of benign pigmented lesions on patients with all . skin types (Fitzpatrick I-VI)
{4}------------------------------------------------
- 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 Cutera enlighten III laser system is indicated for:
- treatment of benign pigmented lesions on patients with ● Fitzpatrick skin types I-III
- tattoo removal for lighter colored tattoo inks, including red and yellow inks, on patients with Fitzpatrick skin types I-III
670 nm
The 670 nm wavelength of the Cutera enlighten III laser system is indicated for treatment of benign pigmented lesions on patients with Fitzpatrick skin types I-III.
- Device Modifications The purpose of this submission is to modify the control software of the previously cleared Cutera enlighten III laser system to enable access to the full parameter range of the enlighten III laser system. The modified and unmodified systems are identical in mechanical, electrical, and thermal design. The modified software will:
- . Change the maximum delivered energy from 600 mJ to 800 mJ for the 1064 nm wavelength and from 300 mJ to 400 mJ for the 532 nm wavelength, while maintaining the previously cleared maximum treatment fluences of 10 J/cm² and 2.5 J/cm² for the 1064 nm and 532 nm wavelengths, respectively.
- Add 9 and 10 mm incremental spot sizes for the 1064 and 532 ● nm wavelengths.
- . Add 2 ns pulse duration for the 670 nm wavelength.
Cutera has determined that no new risks have been introduced due to the above changes, as the maximum treatment fluence for all wavelengths remains unchanged and there are no changes to the intended use or indications for use.
Performance Data: enlighten III Software Verification and Validation Testing Report (V0140 rA1)
The modified and unmodified devices are electrically, mechanically, and thermally identical and comply with the following standards:
- IEC 60601-1 Medical Electrical Equipment Part 1: General ● Requirements for Safety (Edition 3.1, 2012), including:
- IC 60601-1-6 Medical Electrical Equipment Part 1-6: o General Requirements for Safety - Collateral Standard:
{5}------------------------------------------------
Usability (Edition 3.1, 2013)
- IEC 62366 Medical Devices Application of Usability O Engineering to Medical Devices (Edition 1.1, 2014)
- IEC 60601-2-22 Medical Electrical Equipment Part 2: O Particular Requirements for Basic Safety and Essential Performance of Surgical, Cosmetic, Therapeutic and Diagnostic Laser Equipment (Edition 3.1, 2012)
- IEC 60825-1 Safety of Laser Products Part 1: Equipment o Classification and Requirements (Edition 2.0, 2007)
- . The product also fulfills the requirements of AAMI/ANSI ES60601-1:2005+A2 (R2012) + A1.
- . IEC 60601-1-2 Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility (Edition 3, 2007)
Summarv of Technological Characteristics: The modified Cutera enlighten III laser system has the same intended use and indications for use and the same fundamental scientific technology as the previously cleared unmodified Cutera enlighten III laser system (K160488), Quanta System Q-Plus T (K073549), and Cynosure RevLite (K133254), The device design and components are also very similar to these devices. For each of these devices:
- the user interface is located at the front/top of the console;
- . the treatment handpiece is attached to an articulating arm that is connected to the main system console;
- . the laser output at each wavelength is generated within the laser chassis and delivered to the skin through the handpiece attached to the articulated arm; and
- the handpiece allows the spot size on the skin to be . adjusted according to device specifications.
Each system consists of an articulating arm and attached handpiece, as well as an electrically powered system console that produces the laser energy and houses the software and user interface.
The modified Cutera enlighten III laser system provides similar key design aspects, including the same or similar spot sizes, laser wavelengths, pulse widths, and laser types as its predicate and reference devices. The repetition rate of the enlighten III laser system is the same as or within the repetition rate range of the
{6}------------------------------------------------
predicate device. Further, each of the devices presents a range of spot sizes to allow the user to choose the most appropriate spot size for each patient. Therefore, the minor differences do not raise any new safety or effectiveness questions, because the enlighten III parameters are the same as or within the range of the predicate and reference devices.
- Conclusion: The enlighten III laser system is substantially equivalent to the predicate device in terms of indications for use, technical specifications, operating performance features, and general design.
§ 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.