Lotus III Multi-Pulsed Er: Yag Laser System

K182045 · Laseroptek Co., Ltd. · GEX · Dec 27, 2018 · General, Plastic Surgery

Device Facts

• Record ID: K182045
• Device Name: Lotus III Multi-Pulsed Er: Yag Laser System
• Applicant: Laseroptek Co., Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Dec 27, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The LOTUS III Multi-Pulsed Er:YAG Laser System is intended for coagulation, vaporization, ablation or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery), oral surgery, and ophthalmology (skin around the eyes).

Device Story

The LOTUS III is an Er:YAG laser system (2940 nm) used in dermatology, plastic surgery, oral surgery, and ophthalmology. It delivers thermal energy to the epidermis and dermis via an articulated arm and handpiece. The system is operated by a clinician in a clinical setting using a color touchscreen interface and a foot-switch for activation. An embedded processor controls the laser output, which is adjustable in pulse duration, energy, and repetition rate. The device provides coagulation, vaporization, ablation, or cutting of soft tissue, allowing for precise surgical and aesthetic procedures. The system includes an internal water-to-air heat exchanger for cooling. Clinical benefit is derived from the controlled thermal interaction with soft tissue, enabling targeted treatment of skin conditions.

Clinical Evidence

Bench testing only. The device was evaluated for compliance with mandatory performance standards for laser products (21 CFR 1040.10, 1040.11) and consensus standards including AAMI/ANSI ES60601-1 (safety/performance), IEC 60601-1-2 (EMC), IEC 60601-1-6 (usability), IEC 60601-2-22 (surgical laser safety), IEC 60825-1 (laser safety), ISO 14971 (risk management), and ISO 10993-5/10 (biocompatibility).

Technological Characteristics

Er:YAG laser, 2940 nm wavelength. Pulsed output mode. Articulated arm beam delivery with handpiece. Internal water-to-air heat exchanger cooling. 635 nm laser diode aiming beam. Touchscreen interface, foot-switch activation. Dimensions: 298(W) x 819(L) x 936(H) mm; Weight: 80 kg. Electrical: AC 220-230 V, 50/60 Hz. Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1, ISO 14971, ISO 10993.

Indications for Use

Indicated for coagulation, vaporization, ablation, or cutting of soft tissue (skin) in dermatology, plastic surgery, oral surgery, and ophthalmology (skin around the eyes).

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

• LOTUS II Pulsed Er:YAG Laser System (K083253)
• Fotona Fidelis III Er:YAG/Nd:YAG Laser System Family (K093162)
• Fotona Dynamis Pro Family (K143723)

Reference Devices

• PALLAS 308/311 Solid-State UV Laser System (K172639)

Submission Summary (Full Text)

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

Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left and features a stylized human figure. The FDA logo is on the right and includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Laseroptek Co., Ltd. % Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, Minnesota 55313

Re: K182045

Trade/Device Name: Lotus III Multi-Pulsed Er: YAG 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 6, 2018 Received: December 7, 2018

Dear Mark Job:

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 mav, 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

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) N/A

K182045

Device Name

LOTUS III Multi-Pulsed Er:YAG Laser System

Indications for Use (Describe)

The LOTUS III Multi-Pulsed Er: YAG Laser System is intended for coagulation, vaporization, ablation or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery, and ophthalmology (skin around the eyes).

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

| <span></span> Prescription Use (Part 21 CER 801 Subpart D) |
|------------------------------------------------------------|
| <span></span> Over-The-Counter Use (21 CFR 801 Subpart C) |

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

# 5. 510(k) Summary

# 1. General Information

| Applicant/Submitter: | Laseroptek Co., Ltd. |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | #116, #117, #203, #204 Hyundai I Valley 31<br>Galmachi-Ro, Jungwon-Gu<br>Seongnam-Si, Gyeonggido, 13212<br>Rep. of Korea (South Korea)<br>Tel) +82.31.8023.5150<br>Fax) +82.31.8023.5151 |
| Contact Person: | Mina Joo, BT Solutions, Inc. |
| Address: | Unit 402, 91-14 Seolleung-ro, Gangnam-gu, Seoul,<br>Republic of Korea<br>Tel) +82.2.538.9140<br>Email) [e-mail] |
| Preparation Date: | December-17-2018 |

#### 2. Device Name and Code

| Device Trade Name: | LOTUS III Multi-Pulsed Er:YAG Laser System |
|----------------------|----------------------------------------------------------------------------------------|
| Common Name: | Er:YAG Pulsed Surgical Laser |
| Classification Name: | Laser surgical instrument for use in general and plastic<br>surgery and in dermatology |
| Product Code: | GEX |
| Regulation Number: | 878.4810 |
| Classification: | Class II |
| Review Panel: | General & Plastic Surgery (ODE) |

### 3. Technical Characteristics in Comparison to Predicate Device and Reference predicate Devices

LOTUS III Multi-Pulsed Er: Y AG Laser System is substantially equivalent to the following legally marketed predicate device and Reference devices

| 510(K) Number | Primary<br>Predicate Device | Predicate Device | Predicate Device | Proposed Device |
|---------------|-----------------------------|------------------|------------------|-----------------|
| K083253 | K093162 | K143723 | K182045 | |

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

| Manufacturer | Laseroptek Co.,<br>Ltd. | Stegne 7 | Stegne 7 | Laseroptek Co.,<br>Ltd. |
|---------------------------------|-------------------------------------------|---------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|
| Device Name | LOTUS II Pulsed<br>Er:YAG Laser<br>System | Fotona Fidelis<br>III<br>Er:YAG/Nd:YAG Laser System<br>Family | Fotona Dynamis<br>Pro Family | LOTUS III Multi-<br>Pulsed Er:YAG<br>Laser System |
| Clearance Date: | 15 May 2009 | 22 Jan 2010 | 9 April, 2015 | Not available |
| Classification /<br>Regulation | Class 2/ 21 CFR<br>878.4810 | Class 2/ 21 CFR<br>878.4810 | Class 2/ 21 CFR<br>878.4810 | Class 2/ 21 CFR<br>878.4810 |
| Product Code | GEX | GEX | GEX, ONG | GEX |
| Laser Type | Er:YAG | Er:YAG | Er:YAG | Er:YAG |
| Output mode | Pulsed | Pulsed | Pulsed | Pulsed |
| Wavelength | 2940 nm | 2940 nm | 2940 nm | 2940 nm |
| Pulse<br>Characteristics: | | | | |
| Pulse Duration<br>(Pulse Width) | Short: 350 µs<br>Long: 1 ms | 50 – 1000 µs | MSP: 100 us<br>SP: 300 us<br>LP: 600 us<br>VLP: 1000 us<br>XLP: 1500 us<br>SMOOTH mode:<br>250 ms<br>V-SMOOTH<br>mode with L-<br>Runner; 100 ms,<br>200 ms, 300 ms,<br>400 ms and 500<br>ms<br>TURBO | 40 µs<br>200 µs<br>600 µs<br>1 ms<br>5 ms<br>Six pulse mode,<br>SM (200µs x 6<br>shots) |
| Pulse Energy<br>(max) | Short: 1500 mJ<br>Long: 1000 mJ | 20 – 1500 mJ | 30-3000 mJ | 40 µs: 600 mJ<br>200 µs: 3000 mJ<br>600 µs: 900 mJ<br>1 ms: 1000 mJ<br>5 ms: 900 mJ<br>SM: 18000 mJ |
| Average Power<br>(max) | 15 W | up to 20 W | up to 20 W | Up to 30 W |
| Spot size (mm) | Zoom: 1~7mm | - | Zoom: 1~7mm | Black: 1~7mm<br>Blue: 15mm |
| Repetition Rate<br>(Hz) | Up to 10 Hz | Up to 50 Hz | Up to 50 Hz | Up to 40 Hz |
| Fluence max | 191 J/cm² (spot 1<br>mm) | - | 382 J/cm² (spot 1<br>mm) | 382 J/cm² (spot 1<br>mm)<br>SM: 2292 J/cm²<br>(spot 1 mm) |

# 510(k) Summary

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

| Aiming beam | Laser diode, 635<br>nm | Laser diode, 650<br>nm | Laser diode, 650<br>nm | Laser diode, 635<br>nm |
|--------------------------------------------|--------------------------------------------|-----------------------------------|--------------------------------------------|--------------------------------------------|
| <b>Physical</b><br><b>Characteristics:</b> | | | | |
| Beam Delivery<br>System | Articulated Arm<br>with Handpiece | Articulated Arm<br>with Handpiece | Articulated Arm<br>with Handpiece | Articulated Arm<br>with Handpiece |
| Interface | LCD<br>Touchscreen | LCD<br>Touchscreen | LCD<br>Touchscreen | LCD<br>Touchscreen |
| Activation | Via foot-switch | Via foot-switch | Via foot-switch | Via foot-switch |
| Cooling System | Internal Water to<br>Air Heat<br>Exchanger | - | Internal Water to<br>Air Heat<br>Exchanger | Internal Water to<br>Air Heat<br>Exchanger |
| System<br>Dimensions<br>(mm) | 330(W) x<br>941.5mm(D) x<br>905.9mm(H) | - | - | 298(W) x 819(L)<br>x 936(H) |
| System Weight<br>(kg) | 100 kg | - | - | 80 kg |
| Electrical<br>Requirements | AC 220 V, 50/60<br>Hz | - | - | AC 220-230 V,<br>50/60 Hz |

#### 510(k) Summary

Reference Devices:

.

Laseroptek Co. Ltd.'s PALLAS 308/311 Solid-State UV Laser System (K172639) *

*This reference device is referred, of which cleaning method is the same to those of the PALLAS 308/311 Solid-State UV Laser System.

### 4. Device Description

Laseroptek Co. Ltd.'s LOTUS III Pulsed Er:YAG Laser System is an Erbrium:YAG laser with a wavelength of 2940 nm. A set of Er: YAG lasers is controlled by an embedded processor, to be used in dermatology. The laser system uses focusing optics to deliver a pattern of thermal energy to the epidermis and dermis. This system consists of main body, color touch screen, articulated arm, hand piece and foot switch.

### 5. Indications / Intended Use

The LOTUS III Multi-Pulsed Er:YAG Laser System is intended for coagulation, vaporization, ablation or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery), oral surgery, and ophthalmology (skin around the eyes).

### 6. Performance Data

Non-clinical tests: Testing conducted on the LOTUS III Multi-Pulsed Er:YAG Laser System shows that it refers to the relevant mandatory performance standards for laser products 21 CFR

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

#### 510(k) Summary

1040.10 and 1040.11. Other performance, such as electromagnetic compliance, etc, were tested using following standards:

- -LOTUS III Laser System is tested and evaluated according to AAMI/ANSI ES60601-1:2005 and A1:2012. All the results presented in the submission demonstrate general requirements for basic safety and essential performance.
- Effect to the device by electromagnetic disturbances were tested and evaluated according to the FDA-recognized consensus standard IEC 60601-1-2: 2007. All the results presented here demonstrated the requirements and tests for electromagnetic disturbances.
- -LOTUS III laser system is tested and evaluated according to FDA-recognized consensus standard IEC 60601-1-6:2010/AMD1:2013. All the results presented here demonstrated the General requirements for safety - Collateral Standard: Usability.
- LOTUS III Laser System is tested and evaluated according to FDA-recognized consensus standard IEC 60601-2-22: 2007 (Third Edition) + A1:2012. All the results presented here demonstrated the particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment.
- -Safety of laser products is evaluated according to FDA-recognized consensus standard IEC 60825-1: 2007. All the results presented here demonstrated the equipment classification and requirements.
- -Risk management was recorded according to the FDA-recognized consensus standard ISO 14971: 2012. All the results presented here demonstrated the application of risk management to medical devices.
- -Usability was documented according to the FDA-recognized consensus standard IEC 62366: 2008. All the results presented here demonstrated the application of usability engineering to medical devices.
- Biocompatibility was tested and evaluated according to FDA-recognized consensus standard ISO 10993-5: 2009 and ISO 10993-10: 2010.

### 7. Substantial Equivalence

LOTUS III Multi-Pulsed Er: Y AG Laser System, from both a design and clinical perspective, uses similar or identical technology as the cited predicate devices and has the same intended uses. I The general features of LOTUS III are similar to those of the predicates in particular as regards the classification IV laser, the equipment of the cooling system and the electrical specifications. Also, the predicate devices are equipped with a touch screen and activate via foot-switch.

Based upon the predicted overall performance characteristics for the LOTUS III Multi-Pulsed Er:YAG Laser System, Laseroptek Co. Ltd. believes that no significant differences exist in usage of its underlying technological principles between LOTUS III Multi-Pulsed Er: Y AG Laser System and the cited predicate devices.

### 8. Conclusions

On the basis of the information provided in this Summary, Laseroptek Co., Ltd. Believes that LOTUS III Multi-Pulsed Er:YAG Laser System is substantially equivalent to legally commercialized predicate devices for the purposes of this 510 (k) submission.