The Reepot laser system is indicated for the incision, ablation, vaporization of soft tissues for general dermatology, dermatologic and general surgical procedures for coagulation and hemostasis.

532nm Wavelength :

Tattoo removal: light ink (red, tan, purple, orange, skyblue, green)
Removal of Epidermal Pigmented Lesions
Removal of Minor Vascular Lesions including but not limited to telangiectasias
Treatment of Lentigines
Treatment of Cafe-Au-Lait
Treatment of Seborrheic Keratoses
Treatment of Post Inflammatory Hyper-Pigmentation
Treatment of Becker's Nevi, Freckles and Nevi Spilus

Device Description

The reepot Nd;Y AG laser system is comprised of the following major components:

1. Laser system console
1. LCD control panel
1. VSLS handpieces (included camera and LCD display)
1. Footswitch.
1. Accessories

AI/ML Overview

This document is a 510(k) premarket notification for a laser surgical instrument, the reepot Nd:YAG laser system. It focuses on demonstrating substantial equivalence to a predicate device, not on presenting novel performance data for acceptance criteria against a specific medical condition. Therefore, the detailed information requested regarding clinical effectiveness studies, such as the use of test sets, expert adjudication, MRMC studies, or standalone algorithm performance, is not available in this document.

The document primarily addresses safety and technical equivalence, rather than clinical performance acceptance criteria.

However, I can extract the relevant information that is available:

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

The document doesn't provide specific quantitative "acceptance criteria" in terms of clinical efficacy or diagnostic accuracy. Instead, it demonstrates technical performance and safety compliance by comparing its specifications to a predicate device and adhering to recognized standards.

Parameter	reepot Nd;YAG laser system (K222555) (Reported Performance - as presented for equivalence)	CuRAS Nd;YAG laser system (K173038) (Predicate)
Product Code & Regulation No.	GEX, 21 CFR 878.4810	GEX, 21 CFR 878.4810
Laser Medium	Nd:YAG	Nd:YAG
Laser wavelength	532nm	1064nm/532nm
Output energy	Max 0.35J @532 nm	Max 1.6J @1064 nm; Max 0.4J @532 nm
Pulse width	5-20ns	5-20ns
Repetition Rate	1-10Hz	1-15Hz
Spot size	4mm, 6mm	2mm-10mm
Aiming beam	Diode 635nm 5mW	Diode 635nm 5mW
User Interface	LCD touch screen	LCD touch screen
Optical guide	Articulated arm	Articulated arm
Electrical Requirements	220-230VAC, 50-60 Hz	220-230VAC, 50-60 Hz
General Indications for Use	Incision, excision, ablation, vaporization of soft tissues for general dermatology, dermatologic and general surgical procedures for coagulation and hemostasis.	Incision, excision, ablation, vaporization of soft tissues for general dermatology, dermatologic and general surgical procedures for coagulation and hemostasis.
532nm Wavelength Specific Indications	Tattoo removal (light ink), Removal of Epidermal Pigmented Lesions, Removal of Minor Vascular Lesions, etc.	Tattoo removal (light ink), Removal of Epidermal Pigmented Lesions, Removal of Minor Vascular Lesions, etc.

2. Sample size used for the test set and the data provenance:

Not Applicable. No clinical test set data is presented in this 510(k) submission. The submission states, "Based on the similarities in the safety and effectiveness profiles of the subject, reference, and primary predicate devices, no animal or clinical studies were deemed needed to support this submission."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. No clinical test set and thus no ground truth established by experts is mentioned.

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

Not Applicable. No clinical test set is mentioned.

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 surgical instrument, not an AI-powered diagnostic or assistive tool. No MRMC study was conducted or is relevant to this submission.

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

Not Applicable. This device is a laser surgical instrument, not an algorithm.

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

Not Applicable. As no clinical studies were performed for this submission, no ground truth data from such studies is provided. The "ground truth" for this submission revolves around demonstrating that the device's technical specifications and intended use are substantially equivalent to a legally marketed predicate device, and that it adheres to relevant safety standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1).

8. The sample size for the training set:

Not Applicable. This submission is for a physical medical device (laser system), not a machine learning or AI model that requires a training set.

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

Not Applicable. No training set for an AI/ML model is involved.

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 logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

September 23, 2022

Ilooda Co., Ltd. % Do Hyun Kim CEO BT Solutions, Inc. Unit 904, Eonju-ro 86-gil 5, Gangnam-ru Seoul, Seoul 06210 Korea, South

Re: K222555

Trade/Device Name: reepot Nd; 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: September 7, 2022 Received: September 9, 2022

Dear Do Hyun Kim:

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.

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

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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 medical devices and radiation-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,

Jianting Wang 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)

K222555

Device Name

reepot Nd:Y AG laser system

Indications for Use (Describe)

The Reepot laser system is indicated for the incision, ablation, vaporization of soft tissues for general dermatology, dermatologic and general surgical procedures for coagulation and hemostasis.

532nm Wavelength :

Tattoo removal: light ink (red, tan, purple, orange, skyblue, green)
Removal of Epidermal Pigmented Lesions
Removal of Minor Vascular Lesions including but not limited to telangiectasias
Treatment of Lentigines
Treatment of Cafe-Au-Lait
Treatment of Seborrheic Keratoses
Treatment of Post Inflammatory Hyper-Pigmentation
Treatment of Becker's Nevi, Freckles and Nevi Spilus

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

X Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/1 description: The image shows the logo for ilooda. The logo consists of a stylized graphic above the word "ilooda". The graphic is made up of several vertical lines of varying heights, arranged in two rows. The word "ilooda" is written in lowercase letters.

I. General Information [21 CFR 807.92(a) (1)]

Applicant/Submitter:	Ilooda Co., Ltd.9F, 25, Deokcheon-ro 152beon-gil, Manan-gu,Anyang-si, Gyeonggi-do, Republic of KoreaYun-Jung HA (yjha@ilooda.com) / RA Manager
Contact Person:	Do Hyun Kim, BT Solutions, Inc.Unit 904, Eonju-ro 86gil 5,Gangnam-gu, Seoul 06210, Korea.Tel: +82-2-538-9140Email: ceo@btsolutions.co.kr
Preparation Date:	August 17, 2022

II. Names [21 CFR 807.92 (a) (2)]

Trade or Proprietary Name reepot Nd: YAG laser system
Common DeviceName(s) and RegulatoryClass	ProductCode(s)	ClassificationPanel	Regulation
Laser Powered SurgicalInstruments (&Accessories)	GEX	General & PlasticSurgery Panel, 79(SU)	§ 878.4810, Laser surgicalinstrument for use in generaland plastic surgery anddermatology
Class II	Surgical Powered Lasers and Delivery Devices/Hand pieceAccessories

III. Predicate Devices [21 CFR 807.92(a) (3)]

K #	Predicate Device
K173038	CuRAS Nd:YAG Laser

IV. Product Description [21 CFR 807.92(a) (4)]

The reepot Nd;Y AG laser system is comprised of the following major components:

1. Laser system console
1. LCD control panel
1. VSLS handpieces (included camera and LCD display)
1. Footswitch.
1. Accessories

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Image /page/4/Picture/0 description: The image shows the logo for ilooda. The logo consists of a stylized graphic above the word "ilooda". The graphic is made up of vertical lines of varying lengths, arranged in a pattern that resembles a sound wave or equalizer display. The word "ilooda" is written in a lowercase sans-serif font.

The system is intended to be used in user facilities such as hospitals, physicians' offices and medical spas.

V. Intended Use and Indications for Use [21 CFR 807.92(a) (5)]

The reepot Nd;Y AG laser system in indicated for : the incision, excision, ablation, vaporization of soft tissues for general dermatology, dermatologic and general surgical procedures for coagulation and hemostasis.

532nm Wavelength :

Tattoo removal: light ink (red, tan, purple, orange, skyblue, green)
Removal of Epidermal Pigmented Lesions
Removal of Minor Vascular Lesions including but not limited to telangiectasias
Treatment of Lentigines
Treatment of Cafe-Au-Lait
Treatment of Seborrheic Keratoses
Treatment of Post Inflammatory Hyper-Pigmentation
Treatment of Becker's Nevi, Freckles and Nevi Spilus

VI. Summary of Technical Characteristics [21 CFR 807.92(a)(6)]

Table 1: Technical Comparison for the Q-switched Laser
--------------------------------------------------------	--	--

Parameter	reepot Nd;YAG lasersystem(K222555)	CuRAS Nd;YAG laser system(K173038)
Product Code &Regulation No.	GEX21 CFR 878.4810	GEX21 CFR 878.4810
Laser Medium	Nd:YAG	Nd:YAG
Laser wavelength	532nm	1064nm/532nm
Output energy	Max 0.35J @532 nm	Max 1.6J @1064 nmMax 0.4J @532 nm
Pulse width	5-20ns	5-20ns
Repetition Rate	1-10Hz	1-15Hz
Spot size	4mm, 6mm	2mm-10mm
Aiming beam	Diode 635nm 5mW	Diode 635nm 5mW
User Interface	LCD touch screen	LCD touch screen
Optical guide	Articulated arm	Articulated arm
ElectricalRequirements	220-230VAC,50-60 Hz,	220-230VAC,50-60 Hz,
	The reepot Nd:YAG lasersystem inindicated for : theincision,excision,ablation, vaporization of softtissues forgeneral dermatology,dermatologic andgeneral surgical procedures forcoagulation and hemostasis.	The CuRAS Nd:YAG lasersystem inindicated for : theincision,excision,ablation, vaporization of softtissues forgeneral dermatology,dermatologic andgeneral surgical procedures forcoagulation and hemostasis.
Indications forUse	532nm Wavelength :- Tattoo removal: light ink(red, tan,purple, orange, skyblue,green)- Removal of EpidermalPigmentedLesions- Removal of Minor VascularLesionsincluding but not limited totelangiectasias- Treatment of Lentigines- Treatment of Cafe-Au-Lait- Treatment of SeborrheicKeratoses- Treatment of PostInflammatory Hyper-Pigmentation- Treatment of Becker's Nevi,Frecklesand Nevi Spilus	532nm Wavelength :- Tattoo removal: light ink (red,tan,purple, orange, skyblue, green)- Removal of EpidermalPigmentedLesions- Removal of Minor VascularLesionsincluding but not limited totelangiectasias- Treatment of Lentigines- Treatment of Cafe-Au-Lait- Treatment of SeborrheicKeratoses- Treatment of PostInflammatory Hyper-Pigmentation- Treatment of Becker's Nevi,Frecklesand Nevi Spilus

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ilooda
ilooda

VII. Performance Testing [21 CFR 807.92(b)(1)]

IEC 60601-1 Medical Electrical Equipment-Part 1: General Requirements for safety IEC 60601-1-2 Medical Electrical Equipment 1-2 General Requirements for basic safety and essential performance

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Image /page/6/Picture/0 description: The image shows the logo for ilooda. The logo consists of a stylized graphic above the word "ilooda". The graphic is made up of seven vertical bars of varying heights, arranged in a way that suggests sound waves or a digital equalizer. The word "ilooda" is written in a lowercase sans-serif font.

IEC 60601-2-22 Medical Electrical Equipment-Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment

IEC 60825-1 Safety of laser products-Part 1: Equipment Classification, requirements and user's guide

In addition software verification and validation testing was performed and biocompatibility was established.

Clinical Data [21 CFR 807.92(b) (2)] VIII.

Based on the similarities in the safety and effectiveness profiles of the subject, reference, and primary predicate devices, no animal or clinical studies were deemed needed to support this submission.

IX. Conclusion

The reepot Nd; Y AG laser system was found to be substantially equivalent to the predicate devices.

The reepot Nd; Y AG laser system shares the same or similar indications for use, similar design features, and functional features with, and thus is substantially equivalent to the predicate device.

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.