PicoLazer Laser System

K192583 · Rohrer Aesthetics, LLC · GEX · Jan 17, 2020 · General, Plastic Surgery

Device Facts

• Record ID: K192583
• Device Name: PicoLazer Laser System
• Applicant: Rohrer Aesthetics, LLC
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jan 17, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PicoLazer 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 PicoLazer 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 PicoLazer 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

Device Story

PicoLazer is a dual-wavelength (532 nm and 1064 nm) Nd:YAG laser system delivering 450-picosecond pulses. System components include a console, articulated arm, laser handpiece, footswitch, and remote interlock. Operated by clinicians in dermatology, general, or plastic surgery settings. The device emits laser energy to target pigmented lesions or tattoo inks; the short pulse duration (picosecond) facilitates photomechanical disruption of the target. Healthcare providers use the system to perform surgical and aesthetic procedures. Benefits include effective removal of tattoos and treatment of benign pigmented lesions across specified skin types.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including IEC 60601-1 (general safety), IEC 60601-1-2 (EMC), IEC 60601-2-22 (laser safety), and IEC 60825-1 (laser product safety).

Technological Characteristics

Dual-wavelength (532/1064 nm) Nd:YAG laser. Pulse duration: 450 ps. Max energy: 500 mJ (1064 nm), 250 mJ (532 nm). Peak power: 1.3 GW (1064 nm), 0.8 GW (532 nm). Spot size: up to 10 mm. Repetition rate: 1-10 Hz. Energy source: electrical (100-120 VAC or 200-240 VAC).

Indications for Use

Indicated for treatment of benign pigmented lesions and tattoo removal. 1064 nm: benign pigmented lesions (Fitzpatrick I-VI); dark/multicolored tattoos (Fitzpatrick I-VI). 532 nm: benign pigmented lesions (Fitzpatrick I-III); lighter colored tattoos including red/yellow (Fitzpatrick 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

• PicoCare Family (K181272)
• PicoWay Laser System (K170597)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of the seal is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on one line and "ADMINISTRATION" on the line below. The logo is simple and professional, and it is easily recognizable.

Rohrer Aesthetics, LLC Mark Rohrer President 105 Citation Court Homewood, Alabama 35209

Re: K192583

Trade/Device Name: PicoLazer 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: December 17, 2019 Received: December 18, 2019

Dear Mark Rohrer:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

{1}------------------------------------------------

requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Jessica Mavadia-Shukla Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known) K192583

Device Name

PicoLazer

#### Indications for Use (Describe)

The PicoLazer 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 PicoLazer 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 PicoLazer 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

Type of Use (Select one or both, as applicable)

| Restricted Use (Part 21 CFR 201 Subpart D) | <span style="font-size: 20px;"><b> ☑ </b></span> |
|---------------------------------------------|--------------------------------------------------------|
| Over-The-Counter Use (21 CFR 201 Subpart G) | <span style="font-size: 20px;"><b> ☐ </b></span> |

> 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 [e-mail]

"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}------------------------------------------------

## 510(K) Summary PicoLazer Multi-wavelength Laser K192583

This 510(K) Summary of safety and effectiveness for the PicoLazer Multi-wavelength Laser 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: | Rohrer Aesthetics, LLC |
|----------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | Rohrer Aesthetics, LLC<br>105 Citation Court<br>Birmingham, AL 35209 |
| Contact Person: | Mr. Mark Rohrer |
| Telephone: | 205-356-1172 - phone<br>[e-mail] |
| Preparation Date: | September 15, 2019 |
| Device Trade Name: | PicoLazer Laser System |
| Common Name: | Surgical Powered Lasers and Delivery Devices/Hand piece<br>Accessories |
| Regulation Name: | Laser surgical instrument for use in general and<br>plastic surgery and dermatology |
| Regulation Number: | 21 CFR 878.4810 (Product Code: GEX) |
| Legally Marketed Predicate Device1: | PicoCare Family manufactured by Won Tech Co Ltd |
| 510(K) number: | K181272 |
| Legally Marketed Predicate Device 2: | PicoWay Laser System manufactured by Syneron Candela<br>Corporation |
| 510(K) number: | K170597 |
| Regulatory Class: | Class II Prescription Use |
| Description of the PicoLazer Multi-<br>wavelength Laser: | The Rohrer Aesthetics, LLC PicoLazer™ laser system is a<br>dual-wavelength (532 and 1064 nm) Nd:YAG laser system<br>that offers a 450-picosecond pulse duration that produces a<br>maximum energy of 500mJ at 1064nm and 250mJ at<br>532nm.<br><br>The PicoLazer laser system consists of a system console,<br>an articulated arm, a laser handpiece, a footswitch, and a<br>remote interlock plug. Other components necessary for<br>operation, such as power cables, are also included. |

{4}------------------------------------------------

# 510(K) Summary PicoLazer Multi-wavelength Laser

| Indication for Use: | The PicoLazer system is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery. |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 1064nm:<br>The 1064nm wavelength of the PicoLazer laser system is indicated for: |
| | <ul><li>treatment of benign pigmented lesions on patients with Fitzpatrick skin types I-VI.</li><li>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)</li></ul> |
| | 532nm:<br>The 532nm wavelength of the PicoLazer laser system is indicated for: |
| | <ul><li>treatment of benign pigmented lesions on patients with Fitzpatrick skin types I-III</li><li>tattoo removal for lighter colored tattoo inks, including red and yellow inks, on patients with Fitzpatrick skin types I-III</li></ul> |
| Performance Data: | The following performance data was provided in support of the substantial equivalence determination: |
| | IEC 60601-1 Test for Medical Electrical equipment was performed for General Requirements for basic safety and essential performance; |
| | IEC 60601-1-2 Test for Medical Equipment for General Requirements for basic safety and essential performance: electromagnetic compatibility |
| | IEC 60601-2-22 Medical Electrical Equipment-Part 2-22:<br>Requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser Equipment |
| | IEC 60825-1 Safety of laser products - Part 1: Equipment classification, and requirements [Including: Technical Corrigendum 1 (2008), Interpretation Sheet 1 (2007), Interpretation Sheet 2 (2007)] |
| Results of Clinical Study: | A human clinical study was not required as the device is substantially equivalent to the predicate devices. |

{5}------------------------------------------------

# 510(K) Summary PicoLazer Multi-wavelength Laser

Technical Specification Comparison:

| Characteristic | PicoLazer<br>(K192583) | | PicoWay Laser<br>System (K170597) | | PicoCare Family<br>(K181272) | |
|-------------------------------|------------------------|-------|-----------------------------------|--------|------------------------------|-------|
| Wavelength (nm) | 1064nm | 532nm | 1064nm | 532nm | 1064nm | 532nm |
| Laser Type | Nd:YAG | | Nd:YAG | | Nd:YAG | |
| Max Energy (mJ) | 500mJ | 250mJ | 800mJ | 300mJ | 600mJ | 300mJ |
| Peak Power | 1.3GW | 0.8GW | 0.9GW | 0.53GW | 1.33GW | 0.8GW |
| Spot Size | Max 10mm | | Max 10mm | | Max 10mm | |
| Pulse Duration | 450ps | 375ps | 450ps | 375ps | 450ps | |
| Pulse Repetition<br>rate (Hz) | 1~10Hz | | 1~10Hz | | 1~10Hz | |

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Physical Specification:

| aracteristic | PicoLazer<br>(K192583) | PicoWay Laser<br>System (K170597) | PicoCare Family<br>(K181272) |
|------------------|----------------------------------------|-----------------------------------|----------------------------------------|
| Console Weight | 176lbs | 275lbs | 198lbs |
| Console Size | 25(W)x26(D)x48(H)in | 18(W)x27(D)x42(H)in | 18(W)x37(D)x36(H)in |
| Voltage, Current | 100-120 VAC, 20 A<br>200-240 VAC, 15 A | 200-240 VAC, 30A | 100-120 VAC, 20 A<br>220-230 VAC, 15 A |
| Frequency | 50/60Hz | 50/60Hz | 50/60Hz |

Indication for Use Comparison:

| | | PicoLazer<br>(K192583) | PicoWay Laser System<br>(K170597) | PicoCare Family (K181272) |
|--------------|--|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| 1064nm Laser | | Treatment of benign<br>pigmented lesions on<br>patients with Fitzpatrick<br>skin types I-VI | Treatment of benign pigmented<br>lesions on patients with<br>Fitzpatrick skin types I-IV | Tattoo removal for dark<br>colored tattoo inks and for<br>multicolored tattoos<br>containing dark colored<br>tattoo inks on patients with all |
| | | Tattoo removal for dark<br>colored tattoo inks and<br>for multicolored tattoos<br>containing dark colored<br>tattoo inks on patients<br>with all skin types<br>(Fitzpatrick I-VI) | Removal of tattoos for all skin<br>types (Fitzpatrick I-VI) to treat the<br>following colors: black, brown,<br>green, blue, and purple. | skin types (Fitzpatrick I-VI) |
| 532nm Laser | | Treatment of benign<br>pigmented lesions on<br>patients with Fitzpatrick<br>skin types I-III | Treatment of benign pigmented<br>lesions on patients with<br>Fitzpatrick skin types I-IV | Tattoo removal for lighter<br>colored tattoo inks, including<br>red and yellow inks, on<br>patients with Fitzpatrick skin<br>types I-III |
| | | Tattoo removal for<br>lighter colored tattoo<br>inks, including red and<br>yellow inks, on patients<br>with Fitzpatrick skin<br>types I-III | Removal of tattoos for Fitzpatrick<br>skin types I-III to treat the<br>following colors: red, yellow, and<br>orange. | |

{6}------------------------------------------------

## 510(K) Summary PicoLazer Multi-wavelength Laser

Conclusion:

The PicoLaser Laser System's intended use, indications for use and technical specifications are substantially equivalent to the PicoWay Laser System and the PicoCare Family of Lasers.