Predicate Devices

K083889, K132286, K171227, K140249, K123293

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a laser system with different operational modes and wavelengths for dermatological procedures. There is no mention of AI, ML, image processing, or any data-driven decision-making components. The performance studies focus on compliance with electrical and laser safety standards, not AI/ML performance metrics.

Therapeutic

Yes
The device is described as a "surgical laser instrument" intended for various dermatological "procedures" and "treatments" such as tattoo removal, melasma treatment, hair reduction, and treatment of acne scars, wrinkles, and vascular lesions. These are all therapeutic applications. Additionally, the device's adherence to "IEC 60601-2-22:2014 Medical electrical equipment Part 2: Particular requirements for the safety of diagnostic and therapeutic laser equipment" explicitly states its therapeutic intent.

Diagnostic

No

The Finebeam Dual is described as a "surgical laser instrument intended to provide laser energy" for various dermatological procedures such as tattoo removal, treatment of melasma, vascular lesions, and skin resurfacing. Its intended uses are therapeutic, not diagnostic.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "surgical laser instrument" that uses hardware components (Nd:YAG) to generate and emit laser light. This is a hardware device, not software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly describes a surgical laser instrument used for various dermatological procedures performed directly on the patient's body (tattoo removal, treatment of lesions, hair removal, skin resurfacing). IVDs are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
Device Description: The description details the mechanism of a laser, which is a therapeutic device, not a diagnostic one that analyzes biological samples.
Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, calibrators, controls, or any other components typically associated with IVD devices.

Therefore, the Finebeam Dual is a therapeutic medical device, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Finebeam Dual is a surgical laser instrument intended to provide laser energy in two different operation modes (Qswitched (QSW) and long pulse (LPS)) with 1064nm or 532 nm wavelength per use in a variety of dermatological procedures. Each function is intended for:

1. QSW mode with 1064nm single or 1064nm photoacoustic double pulse (PDP) function
Removal dark ink (black, blue, and brown) tattoos;
Treatment melasma, treatment nevus of Ota;
Treatment common nevi;
Removal of lightening of unwanted hair; and
Skin resurfacing procedures for the treatment of acne scars and wrinkles
1. QSW mode with 532nm single function
Removal of light ink (red, tan, purple, and orange) tattoos;
Treatment of vascular lesions including, but not limited to port-wine stains, spider angioma, cherry angioma;
Treatment of pigmented lesions including, but not limited to cafe-au-Lait birthmarks, solar lentigines, Becker's nevi, freckles, common nevi, and nevus spilus;
Treatment of seborrheic keratosis:
Treatment of post-inflammatory hyperpigmentation; and
Skin resurfacing procedures for the treatment of acne scars and wrinkles in the QSW mode function; 3) QSW mode with 1064nm Non-Q function
Removal of unwanted hair, for stable long term or permanent hair reduction and treatment of Pseudofolliculitis Barbae (PFB). The laser is indicated for all skin types, Fitzpatrick I-VI, including tanned skin;
Photocoagulation and hemostasis of pigmented and vascular lesions, such as but not limited to port wine stains, cherry angioma, Hemangiomas, warts, telangiectasias, rosacea, leg veins, Coagulation and hemostasis of soft tissue; and
Treatment of wrinkles

LPS mode

Removal of unwanted hair, for stable long term or permanent hair reduction and treatment of PFB. The lasers are indicated on all skin types Fitzpatrick I-VI including tanned skin;
Photocoagulation and hemostasis of pigmented and vascular lesions, such as but not limited to port wine stains, hemangiomas, warts, telangiectasias, rosacea, leg veins, and spider veins;
Coagulation and hemostasis of soft tissue:
Treatment of wrinkles and acne vulgaris

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

GEX

Device Description

The Finebeam Dual is designed to use neodymium-doped yttrium aluminum garnet (Nd:YAG) to transform and generate high voltage sources for the optical resonator, and the atoms in the source are activated to amplify and emit laser light.

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)

Nonclinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

IEC 60601-1:2005/A1:2012 Medical electrical equipment Part 1: General requirements for basic safety and essential performance
IEC 60601-1-6:2010/A1:2013 Medical electrical equipment Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
IEC 60601-1-2:2014 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
IEC 60601-2-22:2014 Medical electrical equipment Part 2: Particular requirements for the safety of diagnostic and therapeutic laser equipment
IEC 60825-1:2014 Safety of laser products Part 1: Equipment classification and requirements

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.

K083889, K132286, K171227, K140249, K123293

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

0

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".

November 19, 2021

SNJ Co., Ltd. % Jongrak Kim Director Med.com 2202 Gongwon-ro, Guro-gu Seoul, Seoul Teugbyeolsi 08295 Korea, South

Re: K202288

Trade/Device Name: Finebeam 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: October 14, 2021 Received: October 18, 2021

Dear Jongrak 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.

1

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 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

2

Indications for Use

510(k) Number (if known) K202288

Device Name Finebeam Dual

Indications for Use (Describe)

The Finebeam Dual is a surgical laser instrument intended to provide laser energy in two different operation modes (Qswitched (QSW) and long pulse (LPS)) with 1064nm or 532 nm wavelength per use in a variety of dermatological procedures. Each function is intended for:

1. QSW mode with 1064nm single or 1064nm photoacoustic double pulse (PDP) function
Removal dark ink (black, blue, and brown) tattoos;
Treatment melasma, treatment nevus of Ota;
Treatment common nevi;
Removal of lightening of unwanted hair; and
Skin resurfacing procedures for the treatment of acne scars and wrinkles
1. QSW mode with 532nm single function
Removal of light ink (red, tan, purple, and orange) tattoos;
Treatment of vascular lesions including, but not limited to port-wine stains, spider angioma, cherry angioma;
Treatment of pigmented lesions including, but not limited to cafe-au-Lait birthmarks, solar lentigines, Becker's nevi, freckles, common nevi, and nevus spilus;
Treatment of seborrheic keratosis:
Treatment of post-inflammatory hyperpigmentation; and
Skin resurfacing procedures for the treatment of acne scars and wrinkles in the QSW mode function; 3) QSW mode with 1064nm Non-Q function
Removal of unwanted hair, for stable long term or permanent hair reduction and treatment of Pseudofolliculitis Barbae (PFB). The laser is indicated for all skin types, Fitzpatrick I-VI, including tanned skin;
Photocoagulation and hemostasis of pigmented and vascular lesions, such as but not limited to port wine stains, cherry angioma, Hemangiomas, warts, telangiectasias, rosacea, leg veins, Coagulation and hemostasis of soft tissue; and
Treatment of wrinkles

LPS mode

Removal of unwanted hair, for stable long term or permanent hair reduction and treatment of PFB. The lasers are indicated on all skin types Fitzpatrick I-VI including tanned skin;
Photocoagulation and hemostasis of pigmented and vascular lesions, such as but not limited to port wine stains, hemangiomas, warts, telangiectasias, rosacea, leg veins, and spider veins;
Coagulation and hemostasis of soft tissue:
Treatment of wrinkles and acne vulgaris

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

3

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4

o... Itd.

No. 604, Ace-Techno Tower 2, Digital-ro 31-gil 19, Guro-gu, Seoul, Republic of Korea

SECTION 05. 510(k) SUMMARY

This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 807.92.

Submitter 1.

	-	Company Name:	SNJ Co., Ltd.
	-	Name	Hyang-Kee Lee
	-	Address:	No. 604, Ace-Techno Tower 2,
Digital-ro 31-gil 19, Guro-gu,
Seoul, Republic of Korea
	-	Phone Number:	+82-2-866-9005
	-	FDA Registration Number:	3004633032
2.		Application Correspondent
	-	Company Name:	MED.COM
	-	Name	Jongrak Kim
	-	Address:	2202 Gongwon-ro, Guro-gu
Seoul, Republic of Korea
	-	E-mail:	cefdacert@gmail.com
3.		Device Information
	-	Model Name:	Finebeam Dual
	-	Common Name:	Nd:YAG Laser System
	-	Device Class:	Class II under 21 CFR CFR 878.4810
	-	Classification Name:	Powered Laser Surgical Instrument
	-	Product Code:	GEX
4.		Primary Predicate Device
	-	Device Name:	Fotona QX Nd:YAG/KTP Laser System Family
	-	510(k) Number:	K083889
	-	Manufacturer:	Fotona d.d

Additional Predicate Devices 5.

5

-	Device Name:	Hyperion Long Plused Nd:YAG Laser
-	510(k) Number:	K132286
-	Manufacturer:	Laseroptek Co. Ltd.
-	Device Name:	StarWalker Laser System Family
-	510(k) Number:	K171227
-	Manufacturer:	Fotona d.o.o.
-	Device Name:	Long pulse Nd:YAG Laser System
-	510(k) Number:	K140249
-	Manufacturer:	Advanced Technology Laser Company, Ltd
-	Device Name:	Pastelle Q-Switched Nd:YAG Laser System
-	510(k) Number:	K123293
-	Manufacturer:	WON Technology Co., Ltd.

6. Device Description

The Finebeam Dual is designed to use neodymium-doped yttrium aluminum garnet (Nd:YAG) to transform and generate high voltage sources for the optical resonator, and the atoms in the source are activated to amplify and emit laser light.

1. Indications For Use / Intended Use
  The Finebeam Dual is a surgical laser instrument intended to provide laser energy in two different operation modes (Q-switched (QSW) and long pulse (LPS)) with 1064nm or 532 nm wavelength per each function for use in a variety of dermatological procedures. Each function is intended for:
QSW mode with 1064nm single or 1064nm photoacoustic double pulse (PDP) 1) function
- Removal dark ink (black, blue, and brown) tattoos;
- Treatment melasma, treatment nevus of Ota; ı
- Treatment common nevi; -
- Removal of lightening of unwanted hair; and -
- Skin resurfacing procedures for the treatment of acne scars and wrinkles -
1. QSW mode with 532nm single function

6

Co.. Ltd.

No. 604, Ace-Techno Tower 2, Digital-ro 31-gil 19, Guro-gu, Seoul, Republic of Korea

Removal of light ink (red, tan, purple, and orange) tattoos;
Treatment of vascular lesions including, but not limited to port-wine stains, telangiectasias, spider angioma, cherry angioma;
i Treatment of pigmented lesions including, but not limited to cafe-au-Lait birthmarks, solar lentigines, senile lentigines, Becker's nevi, freckles, common nevi, and nevus spilus;
Treatment of seborrheic keratosis; -
Treatment of post-inflammatory hyperpigmentation; and i
Skin resurfacing procedures for the treatment of acne scars and wrinkles in the -QSW mode with 532nm single function;
1. QSW mode with 1064nm Non-Q function
- Removal of unwanted hair, for stable long term or permanent hair reduction and treatment of Pseudofolliculitis Barbae (PFB). The laser is indicated for all skin types, Fitzpatrick I-VI, including tanned skin;
- Photocoagulation and hemostasis of pigmented and vascular lesions, such as but not limited to port wine stains, cherry angioma, Hemangiomas, warts, telangiectasias, rosacea, leg veins, and spider veins, Coagulation and hemostasis of soft tissue; and
- Treatment of wrinkles -
LPS mode 4)
- Removal of unwanted hair, for stable long term or permanent hair reduction and i treatment of PFB. The lasers are indicated on all skin types Fitzpatrick I-VI including tanned skin;
- Photocoagulation and hemostasis of pigmented and vascular lesions, such as but ı not limited to port wine stains, hemangiomas, warts, telangiectasias, rosacea, leg veins, and spider veins;
- Coagulation and hemostasis of soft tissue; i
1. Summary of Technological Characteristics

The Finebeam Dual has the same technological and design characteristics (design, chemical composition, energy source; wavelength, active medium, cooling system, power supply, beam delivery, controls, housing) as the previously cleared devices. The output characteristics are for the intended use the same as those of the predicate devices. All

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Image /page/7/Picture/0 description: The image shows the logo for SNJ Co., Ltd. The logo consists of the letters SNJ in a stylized, sans-serif font, with the letters in a light blue color. To the right of the letters is the company name, "SNJ Co., Ltd.", in a bold, black font. Below the company name is the address, "No. 604, Ace-Techno Tower,", also in black.

systems are based on variable pulse duration power supply technology. All lasers utilize class I aiming beams which pose no hazard to the user. All systems are microprocessor controlled devices. The microprocessor control regulates normal operation, permits parameter selection, and avoids hazard incidence. All systems utilize an internal closed loop water-air heat exchanger circuit for optimal thermal control of the laser cavity. The risk and benefits for the Finebeam Dual are identical to the predicate devices when used for similar clinical applications.

A comparison of the technical specifications for the intended use of the Finebeam Dual with the previously cleared devices is provided the table in section 10.

Non-Clinical Test Conclusion

Nonclinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

IEC 60601-1:2005/A1:2012 Medical electrical equipment Part 1: General requirements for basic safety and essential performance
· IEC 60601-1-6:2010/A1:2013 Medical electrical equipment Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
IEC 60601-1-2:2014 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
IEC 60601-2-22:2014 Medical electrical equipment Part 2: Particular requirements for the safety of diagnostic and therapeutic laser equipment
IEC 60825-1:2014 Safety of laser products Part 1: Equipment classification and requirements

8

SNJ Co., Ltd.

No. 604, Ace-Techno Tower 2, Digital-ro 31-gil 19, Guro-gu, Seoul, Republic of Korea

Comparison of technological characteristics with the predicate device 9.
9.1. Intended use comparison of 532nm single and 1064nm single function in the Q-switched mode

| Device Name | Fotona QX Nd:YAG/KTP Laser System Family
(Predicate) | Finebeam (Proposed) |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | GEX | Same |
| Regulation Number | 21 CFR 878.4810 | Same |
| K number | K083889 | K202288 |
| Applicant | Fotona d.o.o. | SNJ Co., Ltd. |
| Wavelength | 1064nm and 532nm | Same |
| Intended use | 1064 nm wavelength in Q-switched mode:

Removal of dark ink (black, blue and brown)
tattoos
Treatment melasma
Treatment of nevus of Ota
Treatment of common nevi
Removal or lightening of unwanted hair
Skin resurfacing procedures for the treatment
of acne scars and wrinkles

532 nm wavelength in Q-switched mode (nominal
delivered energy of 585 nm and 650 nm with the
optional 585 nm and 650 nm dye converter
handpieces):

Removal of light ink (red, sky blue, green, tan,
purple, and orange) tattoos | With 1064nm single or 1064nm PDP function
Removal dark ink (black, blue and brown)
tattoos
Treatment melasma
Treatment nevus of Ota
Treatment common nevi
Removal of lightening of unwanted hair
Skin resurfacing procedures for the treatment
of acne scars and wrinkles

With 532nm single function

Removal of light ink (red, tan, purple, and
orange) tattoos
Treatment of vascular lesions including, but not
limited to port-wine stains, telangiectasias,
spider angioma, cherry angioma |
| Finebeam Dual – 510(k)
Summary | - SNJ Co., Ltd. - | Page 05-5 of 15 |
| Device Name | Fotona QX Nd:YAG/KTP Laser System Family
(Predicate) | Finebeam (Proposed) |
| | - Treatment of vascular lesions including, but not
limited to:
port wine birthmarks
telangiectasias
spider angioma
Cherry angioma
Spider nevi
Treatment of pigmented lesions including, but
not limited to:
cafe-au-lait birthmarks
solar lentigines
senile lentigines
Becker's nevi
freckles
common nevi
nevus spilus
Treatment of seborrheic keratosis
Treatment of post inflammatory
hyperpigmentation
Skin resurfacing procedures for the treatment
of acne scars and wrinkles. | - Treatment of pigmented lesions including, but
not limited to cafe-au-Lait birthmarks, solar
lentigines, senile lentigines, Becker's nevi,
freckles, common nevi, and nevus spilus
Treatment of seborrheic keratosis
Treatment of post-inflammatory
hyperpigmentation
Skin resurfacing procedures for the treatment
of acne scars and wrinkles |

9

Image /page/9/Picture/0 description: The image shows the SNJ logo. The logo consists of the letters SNJ in a stylized font. The letters are in blue. To the right of the logo is the text "SNJ" with a line underneath it, followed by the text "No. 604,"

SNJ Co., Ltd.

No. 604, Ace-Techno Tower 2, Digital-ro 31-gil 19, Guro-gu, Seoul, Republic of Korea

9.2. Intended use comparison of Non-Q-Switched function in the Q-Switched mode

| Device Name | Fotona QX Nd:YAG/KTP Laser System Family
(Predicate) | Finebeam (Proposed) |
|--------------|---------------------------------------------------------|---------------------|
| Product Code | GEX | Same |

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Image /page/10/Picture/0 description: The image shows the logo for SNJ Co., Ltd. The logo consists of the letters "SNJ" in a stylized font, with the words "SNJ Co., Ltd." written in a more traditional font to the right of the letters. Below the company name is the text "No. 604, Ace-Techno To". The letters "SNJ" are in blue, while the company name and address are in black.

| Device Name | Fotona QX Nd:YAG/KTP Laser System Family
(Predicate) | Finebeam (Proposed) |
|-------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulation Number | 21 CFR 878.4810 | Same |
| K number | K083889 | K202288 |
| Applicant | Fotona d.o.o. | SNJ Co., Ltd. |
| Wavelength | 1064nm | Same |
| Intended use | 1064 nm wavelength in non-Q-switched mode:

Removal of unwanted hair, for stable long term
or permanent hair reduction and for treatment
of PFB. The laser is indicated for all skin types,
Fitzpatrick I-VI, including tanned skin
Photocoagulation and hemostasis of pigmented
and vascular lesions, such as, but not limited
to,port wine stains, hemaongiomae, warts,
telangiectasiae, rosacea, venus lake, leg veins
and spider veins
Coagulation and hemostasis of soft tissue
Treatment of wrinkles
Treatment of mild to moderate inflammatory
acne vulgaris | With 1064nm Non-QSW function
Removal of unwanted hair, for stable long term
or permanent hair reduction and treatment of
PFB (Pseudofolliculitis Barbae). The laser is
indicated for all skin types, Fitzpatrick I-VI,
including tanned skin
Photocoagulation and hemostasis of pigmented
and vascular lesions, such as but not limited to
port wine stains, cherry angioma,
Hemangiomas, warts, telangiectasias, rosacea,
leg veins, and spider veins
Coagulation and hemostasis of soft tissue
Treatment of wrinkles |

Intended use comparison of PDP function in the QSW mode 9.3.

| Device Name | Pastelle
Q-Switched
(Predicate) | Nd:YAG Laser System | Finebeam (Proposed) |
|-------------------|---------------------------------------|---------------------|---------------------|
| Product Code | GEX | | Same |
| Regulation Number | 21 CFR 878.4810 | | Same |

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Image /page/11/Picture/0 description: The image shows the logo for SNJ Co., Ltd. The logo consists of the letters "SNJ" in a stylized font on the left side of the image. To the right of the letters is the company name, "SNJ Co., Ltd." The text is in a bold, sans-serif font.

| Device Name | Pastelle Q-Switched Nd:YAG Laser System
(Predicate) | Finebeam (Proposed) |
|--------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| K number | K123293 | K202288 |
| Applicant | WON Technology Co., Ltd. | SNJ Co., Ltd. |
| Wavelength | 1064nm and 532nm | Same |
| Intended use | 1064 nm wavelength in PTP mode:

Removal of dark ink (black, blue and brown)
tattoos
Treatment of melasma
Treatment of nevus of Ota
Treatment of common nevi
Removal or lightening of unwanted hair
Skin resurfacing procedures for the treatment
of acne scars and wrinkles | With 1064nm PDP function
Removal of dark ink (black, blue and brown)
tattoos
Treatment of melasma
Treatment of nevus of Ota
Treatment of common nevi
Removal or lightening of unwanted hair
Skin resurfacing procedures for the treatment
of acne scars and wrinkles |

9.4. Intended use comparison of LPS mode

Device Name	Fotona XP System Family	Family of Lasers	Finebeam (Proposed)
Product Code	GEX	Same	Same
Regulation Number	21 CFR 878.4810	Same	Same
K number	K090126	K132185	K202288
Applicant	Fotona d.o.o.	Cutera, Inc.	SNJ Co., Ltd.
Wavelength	1064nm	Same	Same
Intended use	- Removal of unwanted hair, for stable long term or permanent hair reduction and	1064 nm wavelength in long pulse mode:	1064 nm wavelength in long pulse mode:

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Image /page/12/Picture/0 description: The image shows the logo for SNJ Co., Ltd. The logo consists of the letters "SNJ" in a stylized font on the left, followed by the text "SNJ Co., Ltd." on the right. Below the company name is the text "No. 604, Ace-Techno Tower".

Device Name	Fotona XP Nd:YAG Laser System Family	Family of CoolGlide Aesthetic Lasers	Finebeam (Proposed)
	for treatment of PFB. The
lasers are indicated on all
skin types Fitzpatrick I-VI
including tanned skin.

Photocoagulation and
hemostasis of pigmented and
vascular lesions, such as but
not limited to port wine stains,
hemangiomas, warts,
telangiectasias, rosacea, leg
veins and spider veins.
Coagulation and hemostasis
of soft tissue.
Incision/excision of soft body
tissue in dermatology.
Soft tissue general surgery
applications-skin incision;
tissue dissection; cornpelte or
partial resection of internal
organs, tumors, lesions;
tissue ablation; vessel
coagulation.
Benign pigmented lesions
such as, but not limited to:
lentigos (age spots), solar
lentigos (sun spots), cafe au
lait macules, seborrheic | - Coagulation and hemostasis
of benign vascular lesions
such as, but not limited to,
port wine stains,
hemangiomas, warts,
telangiectasias, rosacea,
venus lake, leg veins, spider
veins and poikilodlerma of
civatte; and treatment of
benign cutaneous lesions
such as, but not limited to,
warts, scars, striae and
psoriasis. The lasers are also
intended for the treatment of
benign pigmented lesions
such as, but not limited to,
lentigos (age spots), solar
lentigos (sun spots), cafe and au
lait macules, seborrheic
keratoses, nevi, chloasma,
verrucae, skin tags,
keratoses, tattoos (significant
reduction in the intensity of
black and/or blue/black
tattoos) and plaques.
Pigmented lesions to reduce
lesion size, for patients with | - Removal of unwanted hair,
for stable long term or
permanent hair reduction and
treatment of PFB. The lasers
are indicated on all skin types
Fitzpatrick I-VI including
tanned skin.
Photocoagulation and
hemostasis of pigmented and
vascular lesions, such as but
not limited to port wine stains
hemangiomas, warts,
telangiectasias, rosacea, leg
veins, and spider veins.
Coagulation and hemostasis
of soft tissue.
Incision/excision of soft body
tissue.
Treatment of wrinkles and
acne vulgaris | |
| Device Name | Fotona XP Nd:YAG Laser System Family | Family of CoolGlide Aesthetic Lasers | Finebeam (Proposed) | |
| | keratosis, nevi, chloasma (melisma), verruca, skin tags, keratosis, tattoo (significant reduction in the intensity of black and/or blue-black tattoo) and plaques.
Treatment of wrinkles and acne vulgaris. | lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.
Treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles.
Temporary and permanent hair reduction. Permanent hair reduction is defined as long-term, stable reduction in hair counts observed at 6, 9, and 12 months after the end of a treatment regime.
Also indicated for the treatment for pseudofolliculitis barbae (PFB)
Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
All skin types (Fitzpatrick I-VI), including tanned skin. | | |
| Device Name | Fotona XP Nd:YAG Laser
System Family | | Family of CoolGlide Aesthetic
Lasers | Finebeam (Proposed) |
| | | | - Incision/excision and cutting,
ablation,
coagulation/hemostasis of
soft tissue in the performance
of surgical applications in
endoscopy/laparoscopy,
gastroenterology, general
surgery, head and
necklotorhinolaryngology
(ENT), neurosurgery,
oculoplastics, orthopedics,
plastic surgery,
pulmonary/thoracic surgery,
gynecology (e.g.
menorrhagia) and urology. | |

13

SIZ SNJ Co., Ltd.

No. 604, Ace-Techno Tower 2, Digital-ro 31-gil 19, Guro-gu, Seoul, Republic of Korea

14

Image /page/14/Picture/0 description: The image shows the logo for SNJ Co., Ltd. The logo consists of the letters "SNJ" in a stylized font on the left, followed by the words "SNJ Co., Ltd." on the right. Below the company name is the text "No. 604, Ace-Techno Tower". The letters "SNJ" on the left are in a light blue color, while the rest of the text is in black.

9.5. Technical characteristics comparison

Q-Siwtch mode י

| Predicate | Fotona QX Nd:YAGIKTP Laser
System Family | Pastelle Q-Switched
Laser System | Nd:YAG
Finebeam |
|-------------------|-----------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | GEX | Same | Same |
| Regulation Number | 21CFR 878.4810 | Same | Same |
| K number | K083889 | K123293 | K202288 |
| Applicant | Fotona d.o.o. | WON Technology Co., Ltd. | SNJ Co., Ltd. |
| Predicate | Fotona QX Nd:YAGIKTP Laser
System Family | Pastelle Q-Switched
Laser System | Nd:YAG
Finebeam |
| Laser type | Nd:YAG Laser | Same | Same |
| Wavelength | 532nm and 1064nm | Same | Same |
| Pulse frequency | up to 10 Hz | 1-10 Hz | 1-10 Hz |
| Pulse duration | 1064nm Q-switched mode: 5-
20ns
532nm Q-switched mode: 5-
20ns
non-Q switched mode: 0.25ms | Q-switched Mode: 4 to 48 ns
Genesis Mode (Non-Q): 0.08 -
0.48ms | 1064 single (Q-switched mode):