Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the laser technology and user interface, with no mention of AI or ML capabilities.

Therapeutic

Yes
The device is indicated for use in dermatological procedures requiring the coagulation of soft tissue, treatment of actinic keratosis, and treatment of benign pigmented lesions, which are all therapeutic interventions for medical conditions.

Diagnostic

No

The device is described as a laser system for dermatological procedures requiring the coagulation of soft tissue and treatment of various lesions, indicating a therapeutic rather than diagnostic function.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a laser system with hardware components like a thulium laser, optical fiber, handpiece, and footswitch.

IVD (In Vitro Diagnostic)

Based on the provided information, the LaseMD LEO Laser System is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states it's for "dermatological procedures requiring the coagulation of soft tissue, treatment of actinic keratosis, and treatment of benign pigmented lesions". These are direct treatments applied to the patient's body.
Device Description: The description details a laser system that delivers light to the treatment zone. This is a therapeutic device, not a device used to examine specimens from the body.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.

IVD devices are used to examine specimens taken from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. The LaseMD LEO Laser System directly treats conditions on the body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The LaseMD LEO 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 (sunspots) and ephelides (freckles).

Product codes (comma separated list FDA assigned to the subject device)

GEX

Device Description

The LaseMD LEO 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 LCD touch screen gives the user control over the necessary laser system parameters. The LaseMD LEO Laser System is equipped with a 658 nm 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)

An Animal Study Report is included to demonstrate the equivalence between the C1 tip of the Subject device and the Predicate devices.

Bench Testing

The LASEMD LEO Laser System complies with all applicable standards, including ISO 13485:2016, ISO 60601-1 for electrical safety and IEC 60601-1-2 for electromagnetic compatibility. See in Appendix 7.

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.

K171009, K130193

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

Regulation Number and Section

§ 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.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name, "U.S. Food & Drug Administration," written out next to it.

November 12, 2019

Lutronic Global James Childs Clinical Science Director 19 Fortune Drive Billerica, Massachusetts 01821

Re: K192331

Trade/Device Name: LaseMD LEO 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: September 11, 2019 Received: September 13, 2019

Dear James Childs:

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.

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ce determination does not mean that FDA

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 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 (QS) 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Purva Pandya 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

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Indications for Use

510(k) Number (if known) K192331

Device Name LaseMD LEO Laser System

Indications for Use (Describe)

The LaseMD LEO 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 (sunspots) and ephelides (freckles).

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)

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K192331

510(k) Summary for the Lutronic Corporation LASEMD LEO Laser System

This 510(k) Summary is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.

1. General Information
Applicant:	Lutronic Corporation
219, Sowon-ro
Haengsin-dong, Deogyang-gu
Goyang-si, Gyeonggi-do, 410-722
Republic of Korea
Tel: (82) 31-908-3440
Fax: (82) 31-907-3440
Contact Person:	James Childs
Clinical Science Director
Lutronic Global
19 Fortune Drive
Billerica, MA 01821
Tel: 978-584-3464
Email: jchilds@lutronic.com
Summary Preparation Date:	August 23, 2019
2. Names
Trade Name:	LASEMD LEO Laser System
Common Name:	Dermatology Laser
Classification Name:	Laser instrument, Surgical,
Powered
	Product Code: GEX
Panel: General and Plastic

3. Predicate Devices

The LASEMD Laser System and Fraxel DUAL Laser System are surgical instruments for performing dermatological procedures in the treatment of actinic keratosis and treatment of benign pigmented lesions.

Surgery

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510(K) Number	K171009	K130193
Company Name	Lutronic Corporation	Solta Medical, Inc.
Device Name	LASEMD Laser System	Fraxel DUAL 1550/1927
Laser System
Classification Regulation	21 CFR § 878.4810	21 CFR § 878.4810
Classification Name	Powered Laser Surgical
Instrument	Powered Laser Surgical
Instrument
Product Code	GEX	GEX
Device Panel	General & Plastic Surgery	General & Plastic Surgery

4. Device Description

The LaseMD LEO 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 LCD touch screen gives the user control over the necessary laser system parameters. The LaseMD LEO Laser System is equipped with a 658 nm aiming beam.

5. Indications for Use

The LaseMD LEO 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 (sunspots) and ephelides (freckles).

6. Substantial Equivalence

The LaseMD LEO Laser System offers the user the same wavelength, same pulse energy range, same optical train, similar spot sizes, same spot fluence settings and similar per-pass treatment density range as the legally marketed Solta Medical Fraxel DUAL Laser System that is the subject of 510(k) K130193, and LASEMD Laser System (K171009) legally marketed by Lutronic Corporation. The subject and the predicate devices also all operate in pulsed-power mode. The pulsed power setting is user selectable in Expert Mode between 1 – 20W. The maximum power of 20W with the LaseMD LEO system is greater than the maximum pulsed powers available in the predicate devices and is for user convenience. The peak power densities (W/cm2) remain substantially below the ablation threshold and the mechanism of action - thermal coagulation -- is identical to that of the predicate devices. Further, an Animal Study report is included in the submission that establishes equivalence between LaseMD LEO in Energy mode (20W) with the Fraxel Dual device (12W) at similar energy settings. In addition, the LaseMD LEO system operating at 5W or

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lower power settings is identical in design and performance to the LaseMD system at the same power and energy settings. The C5 tip with 350 um spot size provides fluences within the range of the predicate devices. Further, the shot density of the C5 tip includes 144 mB/cm2 and 225 mB/cm2 shot density settings. The shot density of the Predicate device is up to 426 MTZ/cm². At 20 mJ beam energy treatment, the maximum average shot area energy density (J/cm2) for C5 is 0.02 J x 144 mB/cm2 = 2.88 J/cm² and 0.02 J x 225 mB/cm² = 4.5 J/cm² for the 144 mB/cm² and 225 mB/cm2 shot densities, respectively. The average shot area energy density for the Predicate device at the same beam energy is up to 0.02 J x 426 MTZ/cm2 = 8.52 J/cm². Therefore the C5 tip average shot energy density settings are within those of the Predicate device and do not raise any new concerns about safety. No new concerns about effectiveness arise with the 144 mB/cm2 and 225 mB/cm2 shot densities because they are greater than the densities of the cleared Predicate device with 100 mB/cm2 (comparing the square tip in Stamping mode). Final treatment coverage is also controlled by the number of passes and is the same as those of the predicate devices. Therefore, the technological differences between the subject device and the predicate devices are considered to be minor and no new concerns for safety or effectiveness arise.

| Device | LaseMD LEO Laser
System | Fraxel DUAL
1550/1927
Laser System | LASEMD Laser System |
|-----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | To be assigned | K130193 | K171009 |
| Indications for Use | The LaseMD LEO 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). | The Fraxel 1927 nm
laser 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). | 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). |
| Classification | GEX, 21 CFR §
878.4810 | GEX, 21 CFR §
878.4810 | GEX, 21 CFR §
878.4810 |
| Laser Type | Thulium laser | Thulium laser | Thulium laser |
| Laser Wavelength | 1927 nm | 1927 nm | 1927 nm |
| Aiming Beam | 658 nm ≤ 5 mW | 658 nm ≤ 5 mW | 658 nm ≤ 5 mW |
| Beam Delivery | Fiber and Handpiece | Fiber and Handpiece | Fiber and Handpiece |
| Emission Control | Footswitch | Footswitch | Footswitch |
| Display Screen | Yes | Yes | Yes |
| Power | 20 W | 12 W | 5 W |
| Max Pulse Energy | 20 mJ | 20 mJ | 20 mJ |
| Max Pulse Width | 20 ms | 10 ms | 20 ms |
| Pulse Repetition Rate | C1 Tip: 43 -323 Hz
C5 Tip: 46 - 632 Hz | 0 – 3 kHz | 43.5 – 307.7 Hz |
| Laser Beam Spot Size
(Spot Fluence Range)
[Treatment Method] | 200 µm (All C1 Tips)
(3 - 60 J/cm²)
[Stamping or Rolling]
350 µm (C5 Tip)
(1 – 20 J/cm²)
[Stamping] | 200 µm (All Tips)
(3 - 60 J/cm²)
[Rolling] | 100 µm (Cap 100)
(12 - 240 J/cm²)
[Stamping or Rolling]
200 µm (Cap200)
(3 - 60 J/cm²)
[Stamping] |
| Rolling Tx Tips
Function:
Scan Area/Shot
Density
Pulses/Shot
Shot Energy Range | C1 with Rollers
Random:
2.5 mm x 10 mm
Density 40 mB/cm²
(10 Pulses per shot)
10 - 200 mJ
Dynamic:
2 mm x 10 mm
Density 25 mB/cm²
(5 Pulses per shot):
5 - 100 mJ
CW:
4 mm x 10 mm
Density 100 mB/cm²
(40 Pulses per Shot)
40 - 800 mJ | Small tip: 7 mm
(Max at least 426
MTZ/cm²)
Large tip: 15 mm
(Max at least 426
MTZ/cm²) | Caps 100, 200
Random:
2.5 mm x 10 mm
Density 40 mB/cm²
(10 Pulses per shot)
10 - 200 mJ
Dynamic:
2 mm x 10 mm
Density 25 mB/cm²
(5 Pulses per shot):
5 - 100 mJ
CW:
4 mm x 10 mm
Density 100 mB/cm²
(40 Pulses per Shot)
40 - 800 mJ |
| Stamping Tx Tips
Function:
Shot Area
Density
Pulses/Shot
Shot Energy Range | C1 (Square, Comb Tip)
Static:
4 mm x 10 mm
Density: 100 mB/cm²
(40 Pulses per Shot)
40 - 800 mJ

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7. Performance Data

The Company's performance data for the LASEMD LEO Laser System is as follows:

An Animal Study Report is included to demonstrate the equivalence between the C1 tip of the Subject device and the Predicate devices.

Bench Testing

The LASEMD LEO Laser System complies with all applicable standards, including ISO 13485:2016, ISO 60601-1 for electrical safety and IEC 60601-1-2 for electromagnetic compatibility. See in Appendix 7.

8. Conclusion

The intended use of the LASEMD LEO Laser System is virtually identical to the intended use of the predicate devices and the technological characteristics of the LASEMD LEO Laser System. Any differences between the LASEMD LEO Laser System and the predicate devices have no significant influence on safety or effectiveness of the LASEMD LEO

8

Laser System. Therefore, the LASEMD LEO Laser System is substantially equivalent to the predicate devices.