CUTERA PICOSECOND LASER SYSTEM

K140727 · Cutera, Inc. · GEX · Nov 6, 2014 · General, Plastic Surgery

Device Facts

• Record ID: K140727
• Device Name: CUTERA PICOSECOND LASER SYSTEM
• Applicant: Cutera, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Nov 6, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Enlighten Laser System is a multi-wavelength (1064 nm/532 nm), pulsed laser console for tattoo removal. Device features selectable pulse widths (750 ps and 2 ns). Operated by physicians in clinical settings via touchscreen control panel and footswitch. Laser energy delivered through articulated arm to detachable handpiece tips; red diode aiming beam assists targeting. Device targets tattoo ink pigments; energy absorption causes ink fragmentation. Clinical outcomes include tattoo clearing; efficacy assessed by blinded reviewers using photographic scales. Benefits include improved tattoo clearance compared to traditional nanosecond lasers. Safety profile consistent with existing Q-switched laser systems.

Clinical Evidence

Multicenter prospective clinical study (n=42) comparing enlighten laser to a comparator Q-switched Nd:YAG laser. Primary endpoint: tattoo clearance at 6 weeks post-final treatment, assessed by blinded dermatologists using photographic review. Results showed statistically significant mean improvement of 2.54 (95% CI: 2.13–2.94) for enlighten vs 2.17 (95% CI: 1.77–2.57) for comparator (p<0.001). Subgroup analyses confirmed efficacy across pulse durations, wavelengths, and skin types. Safety profile showed expected transient erythema, edema, and pin-point bleeding; no serious adverse events reported.

Technological Characteristics

Multi-wavelength (1064 nm/532 nm) Q-switched Nd:YAG laser. Pulse durations: 750 ps or 2 ns. Max energy: 600 mJ (1064 nm), 300 mJ (532 nm). Max fluence: 10 J/cm² (1064 nm), 2.5 J/cm² (532 nm). Repetition rate: ≤ 10 Hz. Delivery: Articulated arm with detachable handpiece tips. Aiming beam: 635 nm diode. Power: 110 V AC. Standards: IEC 60601-1 (Safety), IEC 60601-1-2 (EMC).

Indications for Use

Indicated for tattoo removal. 1064 nm wavelength: dark colored tattoo inks and multicolored tattoos containing dark colored inks on all skin types (Fitzpatrick I-VI). 532 nm wavelength: lighter colored tattoo inks, including red and yellow, on Fitzpatrick skin types I-III.

Regulatory Classification

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.

Predicate Devices

• Cutera Q-Switch Laser System (K102954)
• Quanta System Q-Plus T (K073549)
• Cynosure PicoSure (K121346)

Submission Summary (Full Text)

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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

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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 [phone] or [phone] 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 [phone] or [phone] 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

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#### 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)

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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: | 415-657-5568 - phone |
| Fax: | 415-715-3568 - fax |
| Email: | [e-mail] |
| Preparation Date: | October 21, 2014 |
| Device Trade Name: | enlighten Laser System |
| Common Name: | Dermatology Laser |
| Classification Name: | Instrument, Surgical, Powered, laser<br>79-GEX, 21 CFR 878.4810 |
| Legally Marketed<br>Predicate Devices: | Cutera Q-Switch Laser System (K102954)<br>Quanta System Q-Plus T (K073549)<br>Cynosure PicoSure (K121346) |
| Device Description: | The enlighten laser system is a multi-wavelength, pulsed laser<br>system designed for tattoo removal. A key feature of the device is<br>its ability to produce multiple laser wavelengths (1064 nm and 532<br>nm) and pulse widths (750 ps and 2 ns, nominal). The laser, power<br>supplies and control electronics are housed inside a console<br>equipped with a touchscreen control panel. The laser treatment<br>parameters are selected using the control panel. Laser emission is<br>activated by depressing a footswitch. The system is operated using<br>110 V mains AC power.<br><br>An articulated arm with rotational mirror knuckles delivers the laser<br>beam from a laser head inside the console to a handpiece. The<br>handpiece is equipped with a detachable tip that determines the<br>spot size of the laser beam on the treatment surface. Multiple tips<br>are provided to vary the spot size as desired for treatment. The<br>beam of a low-power red diode laser is also transmitted through the<br>arm to provide an aiming beam. |
| Intended Use: | The enlighten laser system is intended for use in surgical and<br>aesthetic applications in the medical specialties of dermatology and<br>general and plastic surgery. |
| Specific Indications: | <b>1064 nm:</b><br>The 1064 nm wavelength of the enlighten laser system is indicated<br>for tattoo removal for dark colored tattoo inks and for multicolored<br>tattoos containing dark colored tattoo inks on patients with all skin<br>types (Fitzpatrick I-VI). |
| | <b>532 nm:</b><br>The 532 nm wavelength of the enlighten laser system is indicated<br>for tattoo removal for lighter colored tattoo inks, including red and<br>yellow inks, on patients with Fitzpatrick skin types I-III. |
| Performance Data: | IEC 60601-1 Medical Electrical Equipment - Part 1: General<br>Requirements for Safety |
| | IEC 60601-1-2 Medical Electrical Equipment – Part 1-2: General<br>Requirements for Safety - Collateral Standard: Electromagnetic<br>Compatibility |
| | Nova Software Verification and Validation Testing Report<br>(V0083 r1) |
| Results of Clinical<br>Study: | An IRB-approved multicenter prospective clinical study was<br>conducted to assess the safety and efficacy of the enlighten laser<br>system for tattoo removal. Forty-two subject tattoos of black/blue<br>ink, alone or with other colors, older than one year and 2 to 12<br>square inches in size were enrolled. Forty-one subject tattoos<br>completed the study with 1 lost to follow-up. Subject tattoos were<br>divided into 2 portions for treatment with the Cutera Investigational<br>Q-Switched Nd:YAG laser and a comparator Q-switched Nd:YAG<br>laser respectively, based on randomization assignment. Subject<br>tattoos received 2 to 3 treatments with both laser systems<br>performed 6 weeks apart. Subject tattoos were followed for 6 weeks<br>following final laser treatment. |
| | Standardized photographs were taken at baseline and 6 weeks<br>following the final treatment. Primary efficacy assessments were<br>performed through review of tattoo photographs taken at baseline<br>and 6 weeks post-final treatment by a panel of independent, blinded<br>reviewers (dermatologists). Safety was assessed by the investigator<br>at each visit and via phone surveys (subject reporting) conducted at<br>3 and 14 days following each laser treatment. |
| | Blinded review of baseline and post-treatment tattoo photographs<br>resulted in a clinically and statistically significant mean improvement<br>of 2.54 (95% CI: 2.13–2.94) and 2.17 (95% CI: 1.77–2.57) for the<br>Cutera Investigational device and comparator device, respectively, a<br>6 weeks post-final treatment. The mean difference in reviewer's<br>global assessment of improvement scores between the<br>Investigational and comparator devices was 0.37 (95% CI: 0.20–<br>0.53), indicating that the Investigational device resulted in more<br>clearing than the comparator device at 6 weeks following 2 to 3 |

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#### Attachment 5 510(K) Summary

treatment sessions. This result was statistically significant (p<0.001).

All subjects tolerated treatments well and pain scores were similar with both the investigational and comparator devices (mean pain scores of 4.1 (0.9-0) and 4.4 (0-9) respectively). As expected, subjects experienced erythema, edema and pin-point bleeding in both treatment arms following laser treatment. No serious adverse events were noted.

Subgroup analysis was performed looking at pulse duration, wavelength, and patient skin type. The first subgroup analysis divided subjects into cohorts based on pulse duration: (1) subjects treated with the investigational device using ps pulse durations only; (2) subjects treated with a combination of ps and ns pulse durations in the investigational arm: (3) subjects treated only with ns pulse durations in the investigational arm. The second subgroup analysis divided subjects into cohorts based upon treatment wavelength: (1) treatments were administered using the 532 nm wavelength; (2) only the 1064 nm wavelength was used during laser treatments. The final subgroup analysis divided subjects into cohorts based upon patient skin type: (1) Fitzpatrick skin type IV-VI; (2) Fitzpatrick skin type I-III.

Blinded Reviewer assessment of tattoo clearing at 6 weeks posttreatment for subgroup analysis 1 (Pulse Duration) for the subjects in cohort 1 (treated only with ps pulses) resulted in a clinically and statistically significant mean improvement score of 3.2 (95% Cl: 2.54 – 3.86, p<0.001) in the investigational arm. Subjects in cohort 2 (treated with combination of ps and ns pulses) had a clinically and statistically significant mean improvement score of 2.77 (95% Cl: 2.23 - 3.32, p<0.001). Subjects assigned to cohort 3 (ns pulse only) had a clinically and statistically significant mean improvement score of 2.3 (95% Cl: 1.91 - 2.69, p<0.001). In all cohorts, the investigational device showed a statistically significant higher clearance than the comparator device, with ps pulses only having the greatest difference [0.7 (95% CI: 0.22 - 1.18, p=0.01)], followed by ps and ns [0.46 (95% Cl: 0.10 – 0.81, p=0.015)], and then ns pulses only [0.26 (95% Cl: 0.05 - 0.47, p=0.018)].

Blinded Reviewer assessment results for subgroup analysis 2 (Wavelength) for subjects in cohort 1 of subgroup 2, who were treated with the 532 nm wavelength of the investigational and comparator devices, and cohort 2 of subgroup 2, who were treated with only the 1064 nm wavelength of the investigational and comparator devices, demonstrated clinically and statistically significant mean improvement scores for the investigational treatment arm of 2.6 (95% Cl: 1.91 - 3.29, p<0.001) and 2.53 (95% CI: 2.21 - 2.85, p<0.001) respectively based on blinded reviewers' photographic assessments of tattoo clearing at 6 weeks posttreatment. These improvement scores were consistent with the overall study population.

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### Attachment 5 510(K) Summary

Subgroup analysis was performed based on patient skin type (subgroup analysis 3). At 6 weeks post-final treatment, subjects in cohort 1 of subgroup 3 had a clinically and statistically significant mean improvement score of 2.33 (95% Cl: 1.55 – 3.12. p<0.001) in the investigational arm based on blinded reviewers' photographic assessment. The mean clearing score for the investigational arm in this cohort is slightly lower than the overall study population; however, the mean score in the comparator arm for this cohort was also 0.5 less than that of the comparator arm for the total study population. Subjects with FST I-III had mean tattoo clearing scores in the investigational and comparator arms consistent with the total study population. Safety data showed equivalent adverse event profiles for subjects for both patient cohorts. There were no significant differences in the incidence and severity of adverse events occurring in the investigational treatment arm versus the comparator arm.

Data for 19 additional unilateral picosecond-only treatment sessions was also presented. The blinded reviewers' photographic assessments of subject tattoos at 12 weeks post-final treatment relative to baseline resulted in a mean tattoo clearance rating of 3.4. This clearance is consistent with the 3.2 clearance rating achieved in subjects in cohort 1 subgroup analysis 1, who also received picosecond treatments only. All subjects experienced edema and erythema following laser treatment; the incidence and severity were consistent with those observed in the comparator-controlled clinical study. No unexpected or serious adverse events were reported.

The treatment outcomes observed were consistent with the results of published studies for tattoo removal with nanosecond QS lasers. The comparative results between the investigational and active comparator arms of this study showed substantially equivalent outcomes and adverse events for both treatment arms.

Tattoo removal with the enlighten laser system was found to be safe and effective allowing the conclusion that the enlighten laser system is substantially equivalent to the predicate devices for the requested indication.

Summary of Technological Characteristics:

Conclusion:

The enlighten laser system is substantially equivalent to the predicate devices in terms of indications for use, technical specifications, operating performance features and general design.

See table below

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# Section 5 510(K) Summary

| | enlighten Laser System | Cutera Q-Switch Laser<br>System ( K102954) | Quanta System Q-Plus T<br>(K073549) | Cynosure PicoSure<br>(K121346) |
|----------------------------------|---------------------------------------------------------|---------------------------------------------------------|---------------------------------------------------------|---------------------------------------------------------|
| Wavelength | 1064 nm Nd:YAG laser<br>532 nm Nd:YAG laser | 1064 nm Nd:YAG laser<br>532 nm Nd:YAG laser | 1064 nm Nd:YAG laser<br>532 nm Nd:YAG laser | 755 nm Alexandrite laser |
| Max Pulse Energy | 1064 nm: 600 mJ<br>532 nm: 300 mJ | 1064 nm: 1600 mJ<br>532 nm: 500 mJ | 1064 nm: 1000 mJ<br>532 nm: 500 mJ | 200 mJ |
| Max Fluence | 1064 nm: 10 J/cm²<br>532 nm: 2.5 J/cm² | 1064 nm: 12 J/cm²<br>532 nm: 5 J/cm² | 1064 nm: 22 J/cm²<br>532 nm: 11 J/cm² | 6.37 J/cm² |
| Pulse Duration<br>(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<br>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<br>color touchscreen | Push-button control or LCD<br>color touchscreen | Push-button control or LCD<br>color touchscreen | Push-button control or LCD<br>color touchscreen |
| Treatment Beam<br>Activation | Footswitch | Footswitch | Footswitch | Footswitch |
| Delivery System | Articulated arm with user-<br>detachable handpiece tips | Articulated arm with user-<br>detachable handpiece tips | Articulated arm with user-<br>detachable handpiece tips | Articulated arm with user-<br>detachable handpiece tips |
| Aiming Beam | 635 nm | 635-655 nm | 635 nm | 630-690 nm |
| Handpiece Tips (How<br>Supplied) | Non-sterile, reusable,<br>cleanable | Non-sterile, reusable,<br>cleanable | Non-sterile, reusable,<br>cleanable | Non-sterile, reusable,<br>cleanable |