LASEMD Laser System

K171009 · Lutronic Corporation · GEX · Jun 23, 2017 · General, Plastic Surgery

Device Facts

• Record ID: K171009
• Device Name: LASEMD Laser System
• Applicant: Lutronic Corporation
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jun 23, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The LASEMD Laser System is indicated for use in dermatological procedures requiring the coagulation of soft tissue, treatment of actinic keratosis, and treatment of benign pigmented lesions such as, but not limited to lentigos (age spots), solar lentigos (sun spots) and ephelides (freckles).

Device Story

LASEMD Laser System is a thulium laser (1927 nm) for dermatological procedures. Device uses a footswitch-activated pulsed coherent near-infrared light beam delivered via an optical fiber and handpiece to the treatment zone. An integrated LED touch screen allows user control of laser parameters; a 658 nm aiming beam assists targeting. Operated by clinicians in a clinical setting. Device produces thermal coagulation of soft tissue to treat actinic keratosis and benign pigmented lesions. Benefits include precise tissue coagulation for dermatological conditions.

Clinical Evidence

No clinical data provided. Evidence consists of bench testing (electrical safety per IEC 60601-1, EMC per IEC 60601-1-2) and animal histology confirming equivalent treatment effects to the predicate.

Technological Characteristics

Thulium laser, 1927 nm wavelength. 658 nm aiming beam (≤ 5 mW). Fiber-coupled handpiece delivery. Footswitch activation. Integrated LED touch screen interface. Power: 5 W. Max pulse energy: 20 mJ. Max pulse width: 20 ms. Pulse repetition rate: 43.5 - 307.7 Hz. Spot size: 100-200 μm. Electrical: 100-240V, 50/60 Hz. Standards: ISO 13485:2003, IEC 60601-1, IEC 60601-1-2.

Indications for Use

Indicated for dermatological procedures requiring soft tissue coagulation, treatment of actinic keratosis, and benign pigmented lesions (e.g., lentigos, solar lentigos, ephelides) in patients requiring such dermatological care.

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

• Fraxel DUAL 1550/1929 Laser System (K130193)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 23, 2017

Lutronic Corporation Jhung Vojir VP, Quality and Regulatory Affairs 6 Neshaminy Interplex. Suite 100 Trevose, Pennsylvania 19053

Re: K171009

Trade/Device Name: LASEMD 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: April 3, 2017 Received: April 4, 2017

Dear Jhung Vojir:

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 Actinclude 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 CFR

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Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/ResourcesforYou/Industry/default.htm. 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 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.

Sincerely.

# Jennifer R. Stevenson -S3

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) K171009

Device Name LASEMD Laser System

Indications for Use (Describe)

The LASEMD Laser System is indicated for use in dermatological procedures requiring the coagulation of soft tissue, treatment of actinic keratosis, and treatment of benign pigmented lesions such as, but not limited to lentigos (age spots), solar lentigos (sun spots) and ephelides (freckles).

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

| <span style="font-size:100%;">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size:100%;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |
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|-------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|

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Confidential and Proprietary Information of Lutronic Corporation

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# 6. 510(k) SUMMARY OR STATEMENT

The Company's 510(k) Summary for the LASEMD Laser System is as follows:

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# 510(k) Summary Lutronic Corporation LASEMD Laser System

This 510(k) Summary is being submitted in accordance with 21 CFR § 807.92.

# 1. General Information

| Applicant: | Lutronic Corporation |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 219 Sowon-ro<br>Haengsin-dong, Deogyang-gu<br>Goyang-si, Gyeonggi-do 410-220<br>Republic of Korea<br>Tel: [phone]<br>FAX: [phone] |
| Contact Person: | Jhung Won Vojir, Ph.D.<br>VP of Quality and Regulatory Affairs |
| | Lutronic Corporation<br>6 Neshaminy Interplex, Suite 100<br>Trevose, PA 19053<br>Tel: [phone]<br>FAX: [phone]<br>Email: [e-mail] |
| Summary Preparation Date: | June 20, 2017 |
| 2. Names | |
| Trade Name: | LASEMD Laser System |
| Common Name: | Laser Surgical Instrument |
| Classification Name: | Powered Laser Surgical Instrument<br>Product Code: GEX<br>21 CFR § 878.4810<br>Panel: General & Plastic Surgery |

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#### 3. Predicate Device

The Fraxel DUAL Laser System is a surgical instrument for performing dermatological procedures in the treatment of actinic keratosis and treatment of pigmented lesions.

| 510(K) Number | K130193 |
|---------------------------|------------------------------------|
| Company Name | Solta Medical, Inc. |
| Device Name | Fraxel DUAL 1550/1929 Laser System |
| Classification Regulation | 21 CFR § 878.4810 |
| Classification Name | Powered Laser Surgical Instrument |
| Product Code | GEX |
| Device Panel | General & Plastic Surgery |

#### 4. Device Description

The LASEMD Laser System is a thulium laser, producing a pulsed beam of coherent near-infrared light (1927 nm) upon activation by a footswitch. The beam is then directed to the treatment zone by means of an optical fiber coupled to a handpiece. An integrated LED touch screen gives the user control over the necessary laser system parameters. The LASEMD Laser System is equipped with a 658 nm aiming beam.

# 5. Indications for Use

The LASEMD Laser System is indicated for use in dermatological procedures requiring the coagulation of soft tissue, treatment of actinic keratosis, and treatment of benign pigmented lesions such as, but not limited to lentigos (age spots), solar lentigos (sun spots) and ephelides (freckles).

#### 6. Substantial Equivalence

The LASEMD Laser System is substantially equivalent to the legally marketed Solta Medical Fraxel DUAL Laser System that is the subject of 510(k) K130193.

| Manufacturer | Lutronic Corporation | Solta Medical, Inc. |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device | LASEMD Laser System | Fraxel DUAL 1550/1927<br>Laser System |
| 510(k) Number | K171009 | K130193 |
| Indications for Use | The LASEMD Laser System is<br>indicated for use in<br>dermatological procedures<br>requiring the coagulation of<br>soft tissue, treatment of actinic<br>keratosis, and treatment of<br>benign pigmented lesions such<br>as, but not limited to lentigos<br>(age spots), solar lentigos (sun<br>spots) and ephelides (freckles). | 1927nm: The Fraxel 1927 nm<br>laser is indicated for use in<br>dermatological procedures<br>requiring the coagulation of<br>soft tissue, treatment of actinic<br>keratosis, and treatment of<br>pigmented lesions such as, but<br>not limited to lentigos (age<br>spots), solar lentigos (sun<br>spots) and ephelides<br>(freckles). |

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| Classification | GEX, 21 CFR § 878.4810 | GEX, 21 CFR § 878.4810 |
|-----------------------------|---------------------------------------------|---------------------------------------------|
| Laser Type | Thulium laser | Thulium laser |
| Laser Wavelength | 1927 nm | 1927 nm |
| Aiming Beam | 658 nm ≤ 5 mW | 658 nm ≤ 5 mW |
| Beam Delivery | Fiber and Handpiece | Fiber and Handpiece |
| Emission Control | Footswitch | Footswitch |
| Display Screen | Yes | Yes |
| Power | 5 W | 12 W (1927 nm) |
| Max Pulse Energy | 20 mJ | 20 mJ (1927 nm) |
| Max Pulse Width | 20 ms | 10 ms |
| Pulse Repetition Rate | 43.5 - 307.7 Hz | 0 - 3 kHz |
| Tip Size | 4 mm x 10 mm | Small tip: 7 mm<br>Large tip: 15 mm |
| Dimensions of Laser Console | 413 mm (W) x 324 mm (L) x<br>255.5 mm (D) | 489 mm (W) x 451 mm (L) x<br>444.5 mm (D) |
| Spot Size | 100 $ μ $ m, 200 $ μ $ m | 200 $ μ $ m |
| Weight of Laser System | 33.1 kg | 68.0 kg |
| Electrical Rating | AC 100-240V, 50/60 Hz,<br>Power Consumption | AC 100-240V, 50/60 Hz,<br>Power Consumption |

#### 7. Performance Data

The Company's Performance Data for the LASEMD Laser System is as follows:

# Bench Testing

The LASEMD Laser System complies with all applicable standards, including ISO 13485:2003, ISO 60601-1 for electrical safety and IEC 60601-1-2 for electromagnetic compatibility.

# Animal Testing

Histology confirms that the treatment skin effect of the LASEMD Laser System is the same as the predicate Fraxel DUAL 1927 nm Laser System when used at the same energy settings.

# Clinical Testing

No performance data has been provided since the LASEMD Laser System is equivalent to the previously cleared predicate device with no new issues regarding safety and effectiveness.

#### 8. Conclusion

The LASEMD Laser System and the legally marketed Fraxel DUAL Laser System cleared under 510(k) number K130193, have the same intended use and Indications for Use statement. While the technological characteristics differ between the two systems, the differences have been established to be minor. Performance testing data established that the LASEMD Laser System is as safe and effective as the legally marked predicate

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device and that the LASEMD Laser System does not raise any different questions of safety and effectiveness than the predicate. On this basis and in accordance with 21 CFR \$ 807.100(b), the LASEMD Laser System is substantially equivalent to the Fraxel DUAL Laser System and can be legally marketed in the U.S.