(231 days)
Not Found
No
The summary describes a laser system with multiple wavelengths and pulse widths, controlled via a touchscreen and footswitch. There is no mention of AI, ML, image processing, or any features that would suggest the use of such technologies for analysis, treatment planning, or execution. The performance studies focus on clinical outcomes and blinded assessments, not on the performance of an AI/ML algorithm.
Yes
The device is described as treating "benign pigmented lesions," which are medical conditions, and its use is intended for medical specialties like dermatology and surgery, indicating a therapeutic purpose.
No
The device is a laser system intended for the treatment of benign pigmented lesions, not for diagnosis. It is used in surgical and aesthetic applications.
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.
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.
- Device Description: The enlighten laser system is a laser system designed for treating benign pigmented lesions by applying laser energy directly to the skin. It does not analyze samples taken from the body.
- Intended Use: The intended use is for "surgical and aesthetic applications" and "treatment of benign pigmented lesions." This involves direct intervention on the patient's body, not laboratory analysis of specimens.
- Lack of IVD Characteristics: The description does not mention any components or processes related to sample collection, preparation, or analysis of biological specimens.
Therefore, based on the provided information, the enlighten laser system is a therapeutic device, not an In Vitro Diagnostic device.
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.
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).
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 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.
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)
Results of Clinical Study: Two IRB-approved prospective clinical studies were conducted to assess the safety and efficacy of the enlighten laser system for the 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=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 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 subjects 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 subjects with Fitzpatrick skin types 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% CI: 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.
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.
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.
Cutera Q-Switch Laser System (K102954), Quanta System Q-Plus T (K073549), Cynosure PicoSure (K121346)
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are simple and abstract, and they are the most prominent element of the logo.
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
1
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
2
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
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 5 510(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 – phone | |||
| 415-715-3568 – fax | ||||
| brenton@cutera.com | ||||
| Preparation Date: | August 7, 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 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. |
4
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
5
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
6
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.
7
Section 5 510(K) Summary
| | enlighten Laser System | Cutera Q-Switch Laser
System ( K102954) | Quanta System Q-Plus T
(K073549) | Cynosure PicoSure
(K121346) |
|----------------------------------|---------------------------------------------------------|---------------------------------------------------------|---------------------------------------------------------|---------------------------------------------------------|
| Wavelength | 1064 nm Nd:YAG laser
532 nm Nd:YAG laser | 1064 nm Nd:YAG laser
532 nm Nd:YAG laser | 1064 nm Nd:YAG laser
532 nm Nd:YAG laser | 755 nm Alexandrite laser |
| Max Pulse Energy | 1064 nm: 600 mJ
532 nm: 300 mJ | 1064 nm: 1600 mJ
532 nm: 500 mJ | 1064 nm: 1000 mJ
532 nm: 500 mJ | 200 mJ |
| Max Fluence | 1064 nm: 10 J/cm²
532 nm: 2.5 J/cm² | 1064 nm: 12 J/cm²
532 nm: 5 J/cm² | 1064 nm: 22 J/cm²
532 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, 8
or 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 LCD
color touchscreen | Push-button control or LCD
color touchscreen | Push-button control or LCD
color touchscreen | Push-button control or LCD
color touchscreen |
| Treatment Beam
Activation | 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 (How
Supplied) | Non-sterile, reusable,
cleanable | Non-sterile, reusable,
cleanable | Non-sterile, reusable,
cleanable | Non-sterile, reusable,
cleanable |