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 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.

AI/ML Overview

This document is a 510(k) Summary for the LASEMD Laser System, detailing its substantial equivalence to a predicate device. It primarily focuses on comparing the new device to an already approved one, rather than providing a detailed study of the device's performance against specific acceptance criteria in a clinical setting.

Therefore, many of the requested items, such as a table of acceptance criteria, sample sizes for test and training sets, expert qualifications, and ground truth establishment methods, are not explicitly provided in the document as it's not a clinical performance study report for the LASEMD Laser System itself. Instead, the document relies on the equivalence to a previously cleared device.

However, I can extract information related to the device's technical specifications and how its performance was assessed in comparison to the predicate.

Here's a breakdown of the available information:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" for the LASEMD Laser System's clinical performance in the same way a standalone study would. Instead, the acceptance is based on demonstrating substantial equivalence to a predicate device (Fraxel DUAL Laser System, K130193) in terms of:

Intended Use and Indications for Use: Must be the same.
Technological Characteristics: Differences must be minor and not raise new questions of safety or effectiveness.
Performance (Safety and Effectiveness): Must be as safe and effective as the predicate.

The reported device performance for substantial equivalence is primarily based on:

Bench Testing: Compliance with electrical safety (IEC 60601-1) and electromagnetic compatibility (IEC 60601-1-2) standards.
Animal Testing: Histology confirming the treatment skin effect is the same as the predicate when used at the same energy settings.
Clinical Testing: No new clinical data was provided for the LASEMD system itself, as it was deemed equivalent to the predicate.

Table of Device Performance (focused on comparison to predicate):

Feature/Criteria	LASEMD Laser System Performance	Predicate (Fraxel DUAL 1550/1929 Laser System)
Indications for Use	Coagulation of soft tissue, treatment of actinic keratosis, benign pigmented lesions (lentigos, solar lentigos, ephelides).	1927nm: Coagulation of soft tissue, treatment of actinic keratosis, pigmented lesions (lentigos, solar lentigos, ephelides).
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, Large tip: 15 mm
Spot Size	100 µm, 200 µm	200 µm
Electrical Safety	Complies with IEC 60601-1	(Presumed compliant, as it's a predicate device)
EMC	Complies with IEC 60601-1-2	(Presumed compliant, as it's a predicate device)
Animal Histology (Skin Effect)	Confirmed same as predicate at same energy settings	(Presumed established for predicate)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Test Set Sample Size: Not applicable for a traditional clinical "test set" in this context. The animal study (histology) involved an unspecified number of animals (sample size not given).
Data Provenance: The manufacturer, Lutronic Corporation, is based in the Republic of Korea. The animal testing location and nature (retrospective/prospective) are not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable as the document does not describe a clinical study for the LASEMD Laser System that would require expert ground truth establishment for a diagnostic test. The animal histology would likely be interpreted by veterinary pathologists, but details are not provided.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a laser system, not an AI-based diagnostic tool for which MRMC studies would typically be conducted.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This is a physical medical device (laser system), not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the animal study, the "ground truth" was histology for confirming the treatment skin effect.
For the overall substantial equivalence, the "ground truth" is that the predicate device is legally marketed and generally accepted as safe and effective for its indicated uses.

8. The sample size for the training set

Not applicable. There's no machine learning algorithm being "trained" on a dataset for this device.

9. How the ground truth for the training set was established

Not applicable.

Summary

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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)

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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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-roHaengsin-dong, Deogyang-guGoyang-si, Gyeonggi-do 410-220Republic of KoreaTel: (82) 31-908-3440FAX: (82) 31-907-3440
Contact Person:	Jhung Won Vojir, Ph.D.VP of Quality and Regulatory Affairs
	Lutronic Corporation6 Neshaminy Interplex, Suite 100Trevose, PA 19053Tel: 215-205-2219FAX: 609-488-6958Email: jvojir@lutronic.com
Summary Preparation Date:	June 20, 2017
2. Names
Trade Name:	LASEMD Laser System
Common Name:	Laser Surgical Instrument
Classification Name:	Powered Laser Surgical InstrumentProduct Code: GEX21 CFR § 878.4810Panel: 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

5. Indications for Use

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 1550/1927Laser System
510(k) Number	K171009	K130193
Indications for Use	The LASEMD Laser System isindicated for use indermatological proceduresrequiring the coagulation ofsoft tissue, treatment of actinickeratosis, and treatment ofbenign pigmented lesions suchas, but not limited to lentigos(age spots), solar lentigos (sunspots) and ephelides (freckles).	1927nm: The Fraxel 1927 nmlaser is indicated for use indermatological proceduresrequiring the coagulation ofsoft tissue, treatment of actinickeratosis, and treatment ofpigmented lesions such as, butnot limited to lentigos (agespots), solar lentigos (sunspots) and ephelides(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 mmLarge tip: 15 mm
Dimensions of Laser Console	413 mm (W) x 324 mm (L) x255.5 mm (D)	489 mm (W) x 451 mm (L) x444.5 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,Power Consumption	AC 100-240V, 50/60 Hz,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.

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.