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 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.

AI/ML Overview

Based on the provided text, the device in question is the "LOTUS III Multi-Pulsed Er:YAG Laser System," which is a medical laser system. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a clinical study with detailed performance metrics against specific acceptance criteria for a new AI/imaging device.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets them (especially in the context of AI performance metrics like sensitivity, specificity, human reader improvement, ground truth establishment, training sets, etc.) is not present in this type of regulatory submission for this particular device.

This document is for a traditional medical device (a laser system) and primarily relies on non-clinical performance testing and comparison of technical characteristics to predicate devices to establish substantial equivalence. It does not involve a study of the kind typically performed for AI-powered diagnostic devices that would have the specific performance metrics and study design details requested in your prompt.

Here's why the requested information cannot be found in the provided text:

Device Type: This is a laser system (Er:YAG laser) for general and plastic surgery and dermatology. It is a physical medical device, not an AI/software device that analyzes images or data.
Regulatory Pathway: This is a 510(k) submission, which focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving novel effectiveness or performance against new, specific clinical acceptance criteria through a full-scale clinical trial like a PMA, or a clinical validation study for an AI algorithm.
Performance Data (Section 6): The "Performance Data" section explicitly states that "Non-clinical tests" were conducted, referring to compliance with mandatory performance standards for laser products (e.g., 21 CFR 1040.10 and 1040.11), electromagnetic compliance (IEC 60601-1-2), usability (IEC 60601-1-6, IEC 62366), safety of laser products (IEC 60825-1, IEC 60601-2-22), risk management (ISO 14971), and biocompatibility (ISO 10993). These are engineering and safety standards, not clinical performance metrics for a diagnostic AI.
Absence of Clinical Study Details: There is no mention of:
- Sensitivity, specificity, AUC, or other diagnostic performance metrics.
- Test sets, training sets, or data provenance (countries, retrospective/prospective).
- Experts establishing ground truth, adjudication methods, or MRMC studies.
- Standalone algorithm performance or human-in-the-loop improvement metrics.

In summary, as this document pertains to a traditional laser medical device obtaining 510(k) clearance, the requested details for AI/imaging device performance criteria and studies are not applicable and thus not present in the provided text.

Summary

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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

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

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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)

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

Prescription Use (Part 21 CER 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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5. 510(k) Summary

1. General Information

Applicant/Submitter:	Laseroptek Co., Ltd.
Address:	#116, #117, #203, #204 Hyundai I Valley 31Galmachi-Ro, Jungwon-GuSeongnam-Si, Gyeonggido, 13212Rep. of Korea (South Korea)Tel) +82.31.8023.5150Fax) +82.31.8023.5151
Contact Person:	Mina Joo, BT Solutions, Inc.
Address:	Unit 402, 91-14 Seolleung-ro, Gangnam-gu, Seoul,Republic of KoreaTel) +82.2.538.9140Email) smanager@btsolutions.co.kr
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 plasticsurgery 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	PrimaryPredicate Device	Predicate Device	Predicate Device	Proposed Device
K083253	K093162	K143723	K182045

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Manufacturer	Laseroptek Co.,Ltd.	Stegne 7	Stegne 7	Laseroptek Co.,Ltd.
Device Name	LOTUS II PulsedEr:YAG LaserSystem	Fotona FidelisIIIEr:YAG/Nd:YAG Laser SystemFamily	Fotona DynamisPro Family	LOTUS III Multi-Pulsed Er:YAGLaser System
Clearance Date:	15 May 2009	22 Jan 2010	9 April, 2015	Not available
Classification /Regulation	Class 2/ 21 CFR878.4810	Class 2/ 21 CFR878.4810	Class 2/ 21 CFR878.4810	Class 2/ 21 CFR878.4810
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
PulseCharacteristics:
Pulse Duration(Pulse Width)	Short: 350 µsLong: 1 ms	50 – 1000 µs	MSP: 100 usSP: 300 usLP: 600 usVLP: 1000 usXLP: 1500 usSMOOTH mode:250 msV-SMOOTHmode with L-Runner; 100 ms,200 ms, 300 ms,400 ms and 500msTURBO	40 µs200 µs600 µs1 ms5 msSix pulse mode,SM (200µs x 6shots)
Pulse Energy(max)	Short: 1500 mJLong: 1000 mJ	20 – 1500 mJ	30-3000 mJ	40 µs: 600 mJ200 µs: 3000 mJ600 µs: 900 mJ1 ms: 1000 mJ5 ms: 900 mJSM: 18000 mJ
Average Power(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: 1~7mmBlue: 15mm
Repetition Rate(Hz)	Up to 10 Hz	Up to 50 Hz	Up to 50 Hz	Up to 40 Hz
Fluence max	191 J/cm² (spot 1mm)	-	382 J/cm² (spot 1mm)	382 J/cm² (spot 1mm)SM: 2292 J/cm²(spot 1 mm)

510(k) Summary

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Aiming beam	Laser diode, 635nm	Laser diode, 650nm	Laser diode, 650nm	Laser diode, 635nm
PhysicalCharacteristics:
Beam DeliverySystem	Articulated Armwith Handpiece	Articulated Armwith Handpiece	Articulated Armwith Handpiece	Articulated Armwith Handpiece
Interface	LCDTouchscreen	LCDTouchscreen	LCDTouchscreen	LCDTouchscreen
Activation	Via foot-switch	Via foot-switch	Via foot-switch	Via foot-switch
Cooling System	Internal Water toAir HeatExchanger	-	Internal Water toAir HeatExchanger	Internal Water toAir HeatExchanger
SystemDimensions(mm)	330(W) x941.5mm(D) x905.9mm(H)	-	-	298(W) x 819(L)x 936(H)
System Weight(kg)	100 kg	-	-	80 kg
ElectricalRequirements	AC 220 V, 50/60Hz	-	-	AC 220-230 V,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

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

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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.

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.