(231 days)
The enlighten laser system is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery.
532 nm
The 532 nm wavelength of the enlighten laser system is indicated for the treatment of benign pigmented lesions on patients with Fitzpatrick skin types I-III.
1064 nm
The 1064 nm wavelength of the enlighten laser system is indicated for the treatment of benign pigmented lesions on patients with all skin types (Fitzpatrick I-VI).
The enlighten laser system is a multi-wavelength, pulsed laser system designed for the treatment of benign pigmented lesions. 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.
The provided document describes the enlighten Laser System and its clearance for marketing. While it details the clinical studies performed to establish safety and efficacy, it does not explicitly state quantitative acceptance criteria (e.g., "The device must achieve X% sensitivity and Y% specificity"). Instead, acceptance appears to be based on demonstrating "clinically and statistically significant improvement" and "safety and effectiveness" comparable to predicate devices.
Here's an attempt to extract and infer the requested information based on the available text:
Acceptance Criteria and Device Performance Study for the enlighten Laser System
The enlightenment Laser System's acceptance criteria, while not explicitly defined as pass/fail thresholds in the provided document, appear to center around demonstrating clinically and statistically significant improvement in benign pigmented lesions, good patient satisfaction, and an acceptable safety profile. The study supporting these claims are two IRB-approved prospective clinical studies.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from Study Goals) | Reported Device Performance (as stated in the document) |
|---|---|
| 532 nm Wavelength for Fitzpatrick Skin Types I-III: | 532 nm Wavelength: |
| - Demonstrate clinically and statistically significant improvement (clearing) of benign pigmented lesions. | - Clinically and statistically significant median improvement of 1.50 (on a scale not explicitly defined, but implying a positive change. One-sample Wilcoxon signed rank test, 95% CI: 1.25 - 2.00, P=0.000). |
| - Achieve high consistency and accuracy in blinded photographic identification of before/after photos. | - Reviewers were highly consistent and accurate (kappa of 1, P=0.000) in identification of the before and after photographs (all 20 randomized photos correctly identified by both reviewers). |
| - High patient satisfaction with lesion clearing. | - 95% of subjects reported "satisfied" and "very satisfied" with the improvement. |
| - Acceptable pain levels during treatment. | - All subjects tolerated treatments well (median pain score of 1.4 out of 10). |
| - Acceptable safety profile with resolution of adverse events and no serious adverse events, questionable, precancerous, or malignant lesions. | - Adverse effects resolved without intervention. No serious adverse events noted. No questionable, precancerous or malignant lesions observed during the 24-week follow-up. |
| 1064 nm Wavelength for Fitzpatrick Skin Types I-VI: | 1064 nm Wavelength: |
| - Demonstrate clinically and statistically significant improvement (clearing) of benign pigmented lesions. | - Clinically and statistically significant median improvement score of 0.75 (one-sample Wilcoxon signed rank test, 95% CI: 0.25 - 1.0, p=0.001). Mean improvement score was 0.6. |
| - High patient satisfaction with lesion clearance. | - 91% of subjects expressed satisfaction with lesion clearance. |
| - Acceptable pain levels during treatment. | - All subjects tolerated treatments well (mean pain score of 2.5 ± 1.3 out of 5 - scale implied by range). |
| - Acceptable safety profile with resolution of adverse events and no serious adverse events, questionable, precancerous, or malignant lesions. | - All adverse effects resolved without intervention. No serious adverse events noted. No questionable, precancerous or malignant lesions observed during the 12-week follow-up period. |
| - Histological agreement with published studies (for both wavelengths). | - The treatment outcomes and histology observed in this study for 532-nm and 1064-nm treatment agree with the results of published studies with nanosecond QS lasers, which had the same mechanism of action and tissue interaction as the study device and have a proven baseline efficacy. (Implicitly, the biopsies showed expected tissue changes post-treatment consistent with efficacy and safety). |
| - Substantial equivalence to predicate devices for requested indications (overall criterion for 510(k) clearance). | - Treatment of benign epidermal pigmented lesions with the enlighten laser system was found to be safe and effective, with minimal discomfort and adverse effects, allowing the conclusion that the enlighten laser system is substantially equivalent to the predicate devices for the requested indications.- The enlighten laser system is comparable to the predicate devices in terms of indications for use, technical specifications, operating performance features and general design. |
2. Sample Size Used for the Test Set and Data Provenance
- 532 nm Wavelength Test Set:
- Sample Size: 20 subjects.
- Data Provenance: Prospective clinical study within the US (implied by IRB-approved, no specific country mentioned, but typical for FDA submissions).
- 1064 nm Wavelength Test Set:
- Sample Size: 23 subjects.
- Data Provenance: Prospective clinical study within the US (implied by IRB-approved).
- Histology Test Set:
- Sample Size: Biopsy samples from 2 subjects (volunteer basis).
- Data Provenance: Prospective clinical study within the US (implied by IRB-approved).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: 2 independent dermatologists.
- Qualifications of Experts: The document states "two independent dermatologists" but does not explicitly mention their years of experience or specific board certifications.
4. Adjudication Method for the Test Set
The document describes "Blinded assessment of improvement (clearing) in pigmented lesions was completed by two independent dermatologists."
For the 532 nm study, it states: "The reviewers were highly consistent and accurate (kappa of 1, P=0.000) in identification of the before and after photographs (all 20 randomized before and after photos were correctly identified by both reviewers)."
This suggests that both dermatologists independently reviewed the images. The high kappa value indicates strong agreement, implying that there was likely no formal adjudication needed in this case as they agreed on all assessments. If there had been disagreements, the document does not specify a tie-breaking or adjudication rule (e.g., 2+1 majority voting).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not done.
This device is a laser system for direct treatment, not an AI-based diagnostic or assistive software. The evaluations were on the outcome of the laser treatment on patients, assessed by human experts blinded to the treatment order/timing, not on how human readers perform diagnostic tasks with or without AI.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, in spirit, the primary evaluation of the device itself is standalone. The clinical studies evaluate the direct effect of the enlighten Laser System on human subjects. The device's "performance" is measured by its safety and efficacy in treating benign pigmented lesions, independent of real-time human interpretation assistance for diagnosis. The human experts (dermatologists) in the study were used to assess the outcome of the device's standalone action, not to operate an algorithm or make real-time decisions based on an AI output.
7. The Type of Ground Truth Used
- Primary Ground Truth: Expert consensus of two independent dermatologists based on blinded photographic assessments of lesion improvement (clearing).
- Secondary Ground Truth: Patient questionnaires regarding satisfaction, pain levels, and observed adverse events.
- Tertiary Ground Truth: Histology results from biopsy samples (for 2 subjects) to confirm tissue changes post-treatment.
8. The Sample Size for the Training Set
Not applicable. This document describes a medical device (laser system), not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The clinical studies described are for validation of the device's safety and efficacy.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As stated above, this is a laser system, not an AI/ML algorithm.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 11, 2014
Cutera Incorporated Bradley Renton, Ph.D. Vice President, Regulatory and Medical Affairs Quality Assurance and Compliance Officer 3240 Bayshore Boulevard Brisbane, California 94005
Re: K133945
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: July 18, 2014 Received: July 23, 2014
Dear Dr. 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
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Page 2 - Bradley Renton, Ph.D.
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.
Sincerely yours,
David Krause -S
- 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
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Indications for Use
510(k) Number (if known) K133945
Device Name enlighten Laser System
| Indications for Use (Describe) |
|---|
| The enlighten laser system is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery. |
| 532 nm |
| The 532 nm wavelength of the enlighten laser system is indicated for the treatment of benign pigmented lesions on patients with Fitzpatrick skin types I-III. |
| 1064 nm |
| The 1064 nm wavelength of the enlighten laser system is indicated for the treatment of benign pigmented lesions on patients with all skin types (Fitzpatrick I-VI). |
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Neil R Ogden -S 2014.08.08 10:50:24 -04'00
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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:Fax:Email: | 415-657-5568 – phone415-715-3568 – faxbrenton@cutera.com | |||
| Preparation Date: | August 7, 2014 | |||
| Device Trade Name: | enlighten Laser System | |||
| Common Name: | Dermatology Laser | |||
| Classification Name: | Instrument, Surgical, Powered, laser79-GEX, 21 CFR 878.4810 | |||
| Legally MarketedPredicate 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 lasersystem designed for the treatment of benign pigmented lesions. Akey feature of the device is its ability to produce multiple laserwavelengths (1064 nm and 532 nm) and pulse widths (750 ps and 2ns, nominal). The laser, power supplies and control electronics arehoused inside a console equipped with a touchscreen control panel.The laser treatment parameters are selected using the controlpanel. Laser emission is activated by depressing a footswitch. Thesystem is operated using 110 V mains AC power.An articulated arm with rotational mirror knuckles delivers the laserbeam from a laser head inside the console to a handpiece. Thehandpiece is equipped with a detachable tip that determines thespot size of the laser beam on the treatment surface. Multiple tipsare provided to vary the spot size as desired for treatment. Thebeam of a low-power red diode laser is also transmitted through thearm to provide an aiming beam. |
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Attachment 5 510(K) Summary
- The enlighten laser system is intended for use in surgical and Intended Use: aesthetic applications in the medical specialties of dermatology and general and plastic surgery. Specific Indications: 532 nm The 532 nm wavelength of the enlighten laser system is indicated for the treatment of benign pigmented lesions on patients with Fitzpatrick skin types I-III. 1064 nm The 1064 nm wavelength of the enlighten laser system is indicated for the treatment of benign pigmented lesions on patients with all skin types (Fitzpatrick I-VI). IEC 60601-1 Medical Electrical Equipment – Part 1: General Performance Data: 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 Two IRB-approved prospective clinical studies were conducted to assess the safety and efficacy of the enlighten laser system for the Study: treatment of benign pigmented lesions using the picosecond output of the system. 532 nm Twenty subjects with Fitzpatrick skin types I-III diagnosed with benign pigmented lesions of the hand (lentigines, ephelides and/or seborrheic keratosis) were enrolled and received up to two picosecond 532-nm treatments performed 6 weeks apart. Standardized photographs were taken at baseline and 12 weeks following the final treatment. Blinded assessment of improvement (clearing) in pigmented lesions was completed by two independent dermatologists. Pain levels during treatment and adverse events were recorded during all visits and via phone surveys. Patients were followed to 24 weeks post final treatment for safety assessment. Based on blinded photographic assessments of the 20 subjects, treatments indicated a clinically and statistically significant median improvement of 1.50 (one-sample Wilcoxon signed rank test, 95% CI: 1.25 - 2.00, P=0.000). The reviewers were highly consistent and accurate (kappa of 1, P=0.000) in identification of the before and after photographs (all 20 randomized before and after photos were correctly identified by both reviewers). Based on subject
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Attachment 5 510(K) Summary
questionnaires. 95% of subjects reported that they were "satisfied" and "very satisfied" with the improvement (clearing) in benign pigmented lesions at 12 weeks post final treatment.
All subiects tolerated treatments well (median pain score of 1.4 (0-10)). As expected, subjects experienced erythema (redness), edema (swelling) followed by crusting/scabbing. Blisters were observed in 3 (15%) subjects. About half of the subjects (65%) had purpura (bruising). All adverse effects resolved without intervention. No serious adverse events were noted. No questionable, precancerous or malignant lesions were observed during the 24-week follow-up period.
1064 nm
Twenty three subiects with Fitzpatrick skin tvpes II-VI diagnosed with benign pigmented lesions (lentigines, ephelides, dermatosis papulosa nigra and/or seborrheic keratosis) of the face, body or hands were enrolled and received one picosecond 1064-nm treatment. Standardized photographs were taken at baseline and 6 weeks following the final treatment. Blinded assessment of improvement (clearing) in pigmented lesions was completed by two independent dermatologists. Pain levels during treatment and adverse events were recorded during all visits and via phone surveys. Patients were followed to 12 weeks post final treatment for safety assessment.
Blinded reviewers' photographic assessments of benign pigmented lesion improvement at 6 weeks post treatment for the 23 subject treatment areas revealed a clinically and statistically significant median improvement score of 0.75 (one-sample Wilcoxon signed rank test, 95% Cl: 0.25 - 1.0, p=0.001). The mean improvement score was 0.6. Based on subject questionnaires, 91% of subjects expressed satisfaction with lesion clearance at 6 weeks following laser treatment.
All subjects tolerated treatments well (mean pain score of 2.5 ± 1.3 [1-5]). As expected, all subjects experienced erythema (redness) and edema (swelling). Mild crusting/scabbing was observed in 14 (61%) subjects. All adverse effects resolved without intervention. No serious adverse events were noted. No questionable, precancerous or malignant lesions were observed during the 12-week follow-up period.
Histology
Biopsy samples were obtained on a volunteer basis from two subjects enrolled in the clinical studies for 1064-nm and 532-nm laser treatment immediately post and 6-months post treatment respectively. The histologic sections of the biopsy samples were stained with hematoxylin and eosin (H&E) prior to microscopic examination. Slides for two histologic sections for each biopsy were
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Attachment 5 510(K) Summary
The treatment outcomes and histology observed in this study for 532-nm and 1064-nm treatment agree with the results of published studies with nanosecond QS lasers, which had the same mechanism of action and tissue interaction as the study device and have a proven baseline efficacy.
Treatment of benign epidermal pigmented lesions with the enlighten laser system was found to be safe and effective, with minimal discomfort and adverse effects, allowing the conclusion that the enlighten laser system is substantially equivalent to the predicate devices for the requested indications.
See table below
Summary of Technological Characteristics:
Conclusion:
The enlighten laser system is comparable to the predicate devices in terms of indications for use, technical specifications, operating performance features and general design.
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Section 5 510(K) Summary
| enlighten Laser System | Cutera Q-Switch LaserSystem ( K102954) | Quanta System Q-Plus T(K073549) | Cynosure PicoSure(K121346) | |
|---|---|---|---|---|
| Wavelength | 1064 nm Nd:YAG laser532 nm Nd:YAG laser | 1064 nm Nd:YAG laser532 nm Nd:YAG laser | 1064 nm Nd:YAG laser532 nm Nd:YAG laser | 755 nm Alexandrite laser |
| Max Pulse Energy | 1064 nm: 600 mJ532 nm: 300 mJ | 1064 nm: 1600 mJ532 nm: 500 mJ | 1064 nm: 1000 mJ532 nm: 500 mJ | 200 mJ |
| Max Fluence | 1064 nm: 10 J/cm²532 nm: 2.5 J/cm² | 1064 nm: 12 J/cm²532 nm: 5 J/cm² | 1064 nm: 22 J/cm²532 nm: 11 J/cm² | 6.37 J/cm² |
| Pulse Duration(nominal) | 750 ps or 2 ns | 5-20 ns | 6 ns | ≤ 900 ps |
| Spot Size | 2, 3, 4, 6 or 8 mm | 2-8 mm | Up to 6 mm | Zoom 2-6 mm; fixed 2, 3, 4, 6, 8or 10 mm |
| Output Mode | Pulsed | Pulsed | Pulsed | Pulsed |
| Repetition Rate | ≤ 10 Hz or single shot | ≤ 10 Hz or single shot | ≤ 10 Hz or single shot | ≤ 10 Hz or single shot |
| Laser Media | Q-switched Nd:YAG laser | Q-switched Nd:YAG laser | Q-switched Nd:YAG laser | Q-switched Alexandrite laser |
| User Interface | Push-button control or LCDcolor touchscreen | Push-button control or LCDcolor touchscreen | Push-button control or LCDcolor touchscreen | Push-button control or LCDcolor touchscreen |
| Treatment BeamActivation | Footswitch | Footswitch | Footswitch | Footswitch |
| Delivery System | Articulated arm with user-detachable handpiece tips | Articulated arm with user-detachable handpiece tips | Articulated arm with user-detachable handpiece tips | Articulated arm with user-detachable handpiece tips |
| Aiming Beam | 635 nm | 635-655 nm | 635 nm | 630-690 nm |
| Handpiece Tips (HowSupplied) | Non-sterile, reusable,cleanable | Non-sterile, reusable,cleanable | Non-sterile, reusable,cleanable | Non-sterile, reusable,cleanable |
§ 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.