(464 days)
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:
-
- 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
-
- 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
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.
The provided text is a 510(k) summary for the SNJ Co., Ltd. Finebeam Dual laser system. This document focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and intended use, rather than presenting a study with specific acceptance criteria and performance data for the Finebeam Dual itself.
Therefore, the document does not contain the acceptance criteria and a study that proves the device meets those criteria in the traditional sense of a clinical or analytical performance study.
Instead, the submission argues that the Finebeam Dual is substantially equivalent to previously cleared devices (predicates) because it shares similar technological characteristics and has comparable intended uses. The "performance" discussed primarily refers to its compliance with international safety and electrical standards, and a comparison of its technical specifications with those of the predicate devices.
Here's an breakdown based on the information available in the document, and what is missing:
-
A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as pass/fail criteria for a specific device performance study. The "acceptance" is implicitly related to demonstrating substantial equivalence to predicate devices, meaning its technical specifications and intended uses are similar enough not to raise new questions of safety or effectiveness.
- Reported Device Performance: Instead of a performance study with specific metrics, the document provides a table comparing the Finebeam Dual's technical characteristics (wavelength, pulse frequency, pulse duration, energy, spot size, aiming laser, beam delivery, user interface) with those of its predicate devices in sections 9.1 through 9.5 and 14. For instance, in Q-switched mode, it lists:
- Wavelength: 532nm and 1064nm (Same as predicates)
- Pulse frequency: 1-10 Hz (Same as predicates)
- Pulse duration: 1064nm Q-switched mode: < 25ns, 532nm Q-switched mode: < 25ns, PDP mode: < 25ns, non-Q switched mode: 0.3ms. (Compared to predicates' ranges like 5-20ns for Q-switched, 0.25ms for non-Q)
- Energy (max): 1600mJ at 1064nm, 500mJ at 532nm, 2200mJ at PTP, 3500mJ at Non-Q. (Compared to predicates' values like 1600mJ at 1064nm, 600mJ at 532nm, 5000mJ at Non-Q for Fotona QX; 1300mJ at 1064nm, 500mJ at 532nm, 1600mJ at PTP, 3500mJ at Non-Q for Pastelle)
- Similar comparisons are provided for the Long Pulse mode.
-
Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. The document describes a 510(k) submission based on comparison to predicate devices and non-clinical bench testing for safety standards. It does not mention a "test set" in the context of clinical performance data for the Finebeam Dual device for its indicated uses. The non-clinical tests were conducted to verify compliance with safety standards (IEC 60601-1, IEC 60601-1-6, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1) (page 7). The results demonstrated compliance, but do not involve patient data or specific sample sizes.
-
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 there's no clinical performance test set, there are no experts establishing ground truth for such a set within this document.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No clinical test set is described.
-
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-powered diagnostic imaging device that involves human readers.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This is a laser device, not an algorithm.
-
The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not Applicable. No clinical ground truth data for this device's performance study is presented. The "ground truth" for the 510(k) submission is the established safety and effectiveness of the predicate devices.
-
The sample size for the training set
- Not Applicable. This document is for a medical device (laser system), not an AI algorithm requiring a training set.
-
How the ground truth for the training set was established
- Not Applicable. There is no training set for an AI algorithm.
{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:
-
- 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
-
- 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}------------------------------------------------
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{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-guSeoul, 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.
-
- 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:
- Indications For Use / Intended Use
-
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 -
-
- 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;
-
- 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
-
- 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
{7}------------------------------------------------
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 treatmentof acne scars and wrinkles532 nm wavelength in Q-switched mode (nominaldelivered energy of 585 nm and 650 nm with theoptional 585 nm and 650 nm dye converterhandpieces):- 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 treatmentof acne scars and wrinklesWith 532nm single function- Removal of light ink (red, tan, purple, andorange) tattoos- Treatment of vascular lesions including, but notlimited 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 notlimited to:- port wine birthmarks- telangiectasias- spider angioma- Cherry angioma- Spider nevi- Treatment of pigmented lesions including, butnot 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 inflammatoryhyperpigmentation- Skin resurfacing procedures for the treatmentof acne scars and wrinkles. | - Treatment of pigmented lesions including, butnot limited to cafe-au-Lait birthmarks, solarlentigines, senile lentigines, Becker's nevi,freckles, common nevi, and nevus spilus- Treatment of seborrheic keratosis- Treatment of post-inflammatoryhyperpigmentation- Skin resurfacing procedures for the treatmentof 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 |
{10}------------------------------------------------
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 termor permanent hair reduction and for treatmentof PFB. The laser is indicated for all skin types,Fitzpatrick I-VI, including tanned skin- Photocoagulation and hemostasis of pigmentedand vascular lesions, such as, but not limitedto,port wine stains, hemaongiomae, warts,telangiectasiae, rosacea, venus lake, leg veinsand spider veins- Coagulation and hemostasis of soft tissue- Treatment of wrinkles- Treatment of mild to moderate inflammatoryacne vulgaris | With 1064nm Non-QSW function- Removal of unwanted hair, for stable long termor permanent hair reduction and treatment ofPFB (Pseudofolliculitis Barbae). The laser isindicated for all skin types, Fitzpatrick I-VI,including tanned skin- Photocoagulation and hemostasis of pigmentedand vascular lesions, such as but not limited toport 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 | PastelleQ-Switched(Predicate) | Nd:YAG Laser System | Finebeam (Proposed) |
|---|---|---|---|
| Product Code | GEX | Same | |
| Regulation Number | 21 CFR 878.4810 | Same |
{11}------------------------------------------------
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 treatmentof 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 treatmentof acne scars and wrinkles |
9.4. Intended use comparison of LPS mode
| Device Name | Fotona XP System Family | Nd:YAG Laser | Family of Lasers | CoolGlide Aesthetic | 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: |
{12}------------------------------------------------
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. Thelasers are indicated on allskin types Fitzpatrick I-VIincluding tanned skin.- Photocoagulation andhemostasis of pigmented andvascular lesions, such as butnot limited to port wine stains,hemangiomas, warts,telangiectasias, rosacea, legveins and spider veins.- Coagulation and hemostasisof soft tissue.- Incision/excision of soft bodytissue in dermatology.- Soft tissue general surgeryapplications-skin incision;tissue dissection; cornpelte orpartial resection of internalorgans, tumors, lesions;tissue ablation; vesselcoagulation.- Benign pigmented lesionssuch as, but not limited to:lentigos (age spots), solarlentigos (sun spots), cafe aulait macules, seborrheic | - Coagulation and hemostasisof benign vascular lesionssuch as, but not limited to,port wine stains,hemangiomas, warts,telangiectasias, rosacea,venus lake, leg veins, spiderveins and poikilodlerma ofcivatte; and treatment ofbenign cutaneous lesionssuch as, but not limited to,warts, scars, striae andpsoriasis. The lasers are alsointended for the treatment ofbenign pigmented lesionssuch as, but not limited to,lentigos (age spots), solarlentigos (sun spots), cafe and aulait macules, seborrheickeratoses, nevi, chloasma,verrucae, skin tags,keratoses, tattoos (significantreduction in the intensity ofblack and/or blue/blacktattoos) and plaques.- Pigmented lesions to reducelesion size, for patients with | - Removal of unwanted hair,for stable long term orpermanent hair reduction andtreatment of PFB. The lasersare indicated on all skin typesFitzpatrick I-VI includingtanned skin.- Photocoagulation andhemostasis of pigmented andvascular lesions, such as butnot limited to port wine stainshemangiomas, warts,telangiectasias, rosacea, legveins, and spider veins.- Coagulation and hemostasisof soft tissue.- Incision/excision of soft bodytissue.- Treatment of wrinkles andacne 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 LaserSystem Family | Family of CoolGlide AestheticLasers | Finebeam (Proposed) | |
| - Incision/excision and cutting,ablation,coagulation/hemostasis ofsoft tissue in the performanceof surgical applications inendoscopy/laparoscopy,gastroenterology, generalsurgery, head andnecklotorhinolaryngology(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 LaserSystem Family | Pastelle Q-SwitchedLaser System | Nd:YAGFinebeam |
|---|---|---|---|
| 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 LaserSystem Family | Pastelle Q-SwitchedLaser System | Nd:YAGFinebeam |
| 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: 5-20ns532nm Q-switched mode: 5-20nsnon-Q switched mode: 0.25ms | Q-switched Mode: 4 to 48 nsGenesis Mode (Non-Q): 0.08 -0.48ms | 1064 single (Q-switched mode):< 25ns532 single (Q-switched mode): <25nsPDP mode: < 25nsnon-Q switched mode: 0.3ms |
| Energy (max) | 1600mJ at 1064nm600mJ at 532nm5000mJ at Non-Q mode | 1300mJ at 1064nm500mJ at 532nm1600mJ at PTP3500mJ at Non-Q mode | 1600mJ at 1064nm500mJ at 532nm2200mJ at PTP3500mJ at Non-Q |
| Spot size | - R28 Handpiece: 1064nm = 2 ~ 8 mm: 532nm = 2 ~ 8 mm- R585, 650 Handpiece: 585nm = 2 ~ 4: 650nm = 2 ~ 4 | - Zoom Handpiece: 1064 nm, 532 nm = 2~10 mm- Collimator Handpiece: 1064 nm = 8 mm- Fractional Handpiece (Option): 1064 nm = unknown the size perspotArea: 5x5 mm² (DOE,Diffractive optical element),Spacing between micro spot:unknown | - Zoom Handpiece: 1064 nm = 2 |
| Aiming laser | 650nm diode laser (<5mW),Class III | 650nm diode laser (<5mW), ClassIII | 655nm diode laser (<5mW),Class III |
| Beam Delivery | Articulated arm | same | same |
| Predicate | Fotona QX Nd:YAGIKTP Laser System Family | Pastelle Q-Switched Laser System Nd:YAG | Finebeam |
| User interface | Push button control | LCD Touch screen | LCD Touch screen |
| - Long Pulse mode | |||
| Predicate | Fotona XP Nd:YAG Laser System Family | Family of CoolGlide Aesthetic Lasers | Finebeam |
| Product Code | GEX | Same | Same |
| Regulation Number | 21CFR 878.4810 | Same | Same |
| K number | K090126 | K132185 | K202288 |
| Applicant | Fotona d.o.o. | Cutera, Inc. | SNJ Co., Ltd. |
| Laser type | Nd:YAG Laser | Same | Same |
| Wavelength | 1064nm | 1064 nm | 532nm and 1064nm |
| Pulse frequency | up to 75 Hz | 1-10 Hz and single shot | 1-10 Hz |
| Pulse duration | 0.1-300ms | 0.1-300ms | Long Pulse mode: 0.5-300ms |
| Energy (max) | Up to 120 J | up to 300J/cm2 | 60J at LPS (Long pulse) |
| Spot size | R33 Handpiece: 2 - 10 mmR34 Handpiece: 15 - 20 mm | Integrated 3, 5, 8, 10 mm | - Zoom Handpiece: 1064 nm = 2 |
| Aiming laser | 650nm diode laser (<5mW),Class III | 630-680 nm | 655nm diode laser (<5mW),Class III |
| Predicate | Fotona XP Nd:YAG Laser System Family | Family of CoolGlide Aesthetic Lasers | Finebeam |
| Beam Delivery | Optical fiber | Optical fiber | Articulated arm |
| User interface | Push button control | Push button control | LCD Touch screen |
{15}------------------------------------------------
Image /page/15/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 company name "SNJ Co., Ltd." on the right. Below the company name is the text "No. 604, Ace-Techno To".
{16}------------------------------------------------
Image /page/16/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 To".
{17}------------------------------------------------
Image /page/17/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 address, "No. 604, Ace-Techno".
10. Comparison discussion
-
10.1. Intended use
Each device is intended for use of surgical laser device in Dermatology. -
10.2. Technological characteristics
The Finebeam Dual has the same technological and design characteristics as the previously cleared devices. The output characteristics are for the intended use the same as those of the predicate devices. All 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 risk and benefits for the Finebeam Dual are identical to the predicate devices when used for similar clinical applications. -
10.3. Performance characteristics
Finebeam Dual is designed, tested, and manufactured per both mandatory and voluntary standards. -
- Conclusion
Based on the data submitted in this 510(k) submission, the Finebeam Dual is substantially equivalent in terms of intended use, technological characteristics, and performance to the proposed device, Long Pulse Nd:YAG Laser System,
- Conclusion
{18}------------------------------------------------
Image /page/18/Picture/0 description: The image shows the logo and address of SNJ Co., Ltd. The logo consists of the letters "SNJ" in a stylized font. The address is "No. 604, Ace-Techno Tower 2, Digital-ro 31-gil 19, Guro-gu, Seoul, Republic of Korea."
is determined to be Substantially Equivalent (SE) to the predicate device, XP Nd:YAG Laser System and CoolGlide Aesthetic Lasers, in respect of safety and effectiveness.
§ 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.