MOSAIC 3D (Surgical Laser)

K233550 · Lutronic Aesthetic · ONG · Jan 2, 2024 · General, Plastic Surgery

Device Facts

• Record ID: K233550
• Device Name: MOSAIC 3D (Surgical Laser)
• Applicant: Lutronic Aesthetic
• Product Code: ONG · General, Plastic Surgery
• Decision Date: Jan 2, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MOSAIC 3D Laser System is indicated for use in dermatological procedures requiring the coagulation of soft tissue, as well as for fractional skin resurfacing procedures.

Device Story

MOSAIC 3D is a non-ablative fractional Er:Glass laser (1550 nm) for dermatological use. System comprises main body, handpiece with optical fiber, footswitch, and protective goggles. Laser energy is delivered via various tips (roller, sapphire, comb, pill) to create microscopic treatment zones (MTZ) in the dermis. Principle of operation is fractional photothermolysis; laser energy is absorbed by water in tissue, inducing thermal coagulation while sparing surrounding healthy skin. Operated by clinicians in a professional setting. User configures treatment parameters (energy, density, pattern) via LCD touchscreen interface. Output is controlled thermal damage to tissue, intended to facilitate skin resurfacing and coagulation. Benefits include precise, controlled thermal effects with reduced recovery time compared to non-fractional methods.

Clinical Evidence

Clinical study of 15 patients treated at various settings. Histological evaluation of biopsies taken on day of treatment and subsequent days showed coagulation formation followed by healing within 4 days. Reported side effects were mild erythema and edema, resolving by end of day. No adverse events reported.

Technological Characteristics

Non-ablative fractional Er:Glass fiber laser; 1550 nm wavelength; 4-70 mJ pulse energy; 169.8-447.4 Hz repetition rate. Air cooling. Class I, Type B electrical safety. Biocompatibility per ISO 10993-5, 10993-10, 10993-23. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1.

Indications for Use

Indicated for dermatological procedures requiring soft tissue coagulation and fractional skin resurfacing. No specific age or gender restrictions provided.

Regulatory Classification

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.

Predicate Devices

• Lutronic Corporation MOSAIC HP (K080932)

Reference Devices

• Solta Medical, Inc. Fraxel Dual 1550 (K130193)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

January 2, 2024

Lutronic Aesthetic % Kevin O'connell VP Global Regulatory Affairs Lutronic Corporation Lutronic Center 219. Sowon-Ro Deogyang-Gu, Goyang-si 410220 Korea. South

Re: K233550

Trade/Device Name: MOSAIC 3D (Surgical Laser) 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: ONG, GEX Dated: November 3, 2023 Received: November 3, 2023

Dear Kevin O'connell:

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 (the 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 available 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}------------------------------------------------

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Jianting Wang Digitally signed by Jianting
Wang -s -2 Date: 2024.01.02 20:19:37 -05'00'

for Tanisha Hithe Assistant Director DHT4A: Division of General Surgery Devices

{2}------------------------------------------------

OHT4: Office of Surgical & Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

### Indications for Use

510(k) Number (if known) K233550

Device Name MOSAIC 3D Laser System

Indications for Use (Describe)

The MOSAIC 3D Laser System is indicated for use in dermatological procedures requiring the coagulation of soft tissue, as well as for fractional skin resurfacing procedures.

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

| <label><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> |
|-------------------------------------------------------------------------------------------------|
| <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the Lutronic logo. The logo is white text on a red background. The text is the word "LUTRONIC" with a registered trademark symbol to the right of the "C".

### A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92.

| 807.92(a)(1) - Submitter Information | |
|---------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name | Lutronic Corporation |
| Address | Lutronic Center<br>219, Sowon-Ro<br>Deogyang-Gu, Goyang-Si, KR 410220 |
| Phone number | 978-888-1426 |
| Fax number | N/A |
| Establishment Registration<br>Number | 1222993 |
| Name of contact person | Sarah Dunne<br>Senior Regulatory Affairs Specialist, Lutronic Aesthetic<br>19 Fortune Drive<br>Billerica, MA, 01821 |
| Date prepared | 02 JANUARY 2024 |
| 807.92(a)(2) - Name of device | |
| Trade or proprietary name | MOSAIC 3D |
| Common or usual name | Surgical Laser |
| Classification name | Laser Surgical Instrument for use in General and Plastic Surgery and in<br>Dermatology |
| Classification panel | General and Plastic Surgery |
| Regulation | 21 CFR 878.4810 |
| Product Code(s) | ONG (primary), GEX (secondary) |
| 807.92(a)(3) - Legally marketed device(s) to which equivalence is claimed | |
| | Lutronic Corporation K080932 (06/09/2008) Predicate<br>Solta Medical, Inc K130193 (06/14/2013) Reference |
| 807.92(a)(4) - Device description | |
| | The MOSAIC 3D Laser System is a non-ablative fractional Er:Glass (Erbium<br>Glass) laser with a wavelength of 1550 nm. It uses Er:Glass to emit a laser<br>beam that is then emitted onto the treatment area via the handpiece connected<br>to the optical fiber of the main body of the system. It is comprised of a main<br>body, a handpiece connected to an optical fiber, a tip, a footswitch, and<br>goggles for laser protection. The laser beam is emitted onto the area to be<br>treated through the tips (roller tip, sapphire tip, comb tip, pill tip) connected<br>to the handpiece. |
| | When the beam contacts tissue the laser beam emits many separate<br>microbeams and creates a microscopic treatment zone (MTZ). Thermal<br>coagulation is then induced in the dermis using the principle of fractional<br>photo thermolysis, sparing the normal skin tissue surrounding the MTZ area.<br>When the laser beam is emitted onto skin tissue, the energy of the beam is<br>absorbed by specific tissues or chromophores such as water and is then<br>converted into thermal energy, causing thermal damage to produce a<br>therapeutic effect.<br>The MOSAIC 3D Laser System is controlled via a LCD touchscreen guided<br>user interface in the front of the device, which is used to easily configure<br>optimal treatment parameters and check parameters set in the device in the<br>current system mode. |
| 807.92(a)(5) Intended use of the device | |
| Indications for use | The MOSAIC 3D Laser System is indicated for use in dermatological<br>procedures requiring the coagulation of soft tissue, as well as for fractional<br>skin resurfacing procedures. |

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows the Lutronic logo. The logo is white text on a red background. The word "LUTRONIC" is written in all capital letters.

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image shows the Lutronic logo. The logo is white text on a red background. The text reads "LUTRONIC" in all capital letters, with a small circle containing an R in the upper right corner of the C.

| 807.92(a)(6) Summary of the technological characteristics of the device compared to the predicate | | | |
|---------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | MOSAIC 3D | MOSAIC HP<br>K080932 | Fraxel Dual 1550<br>K130193 (reference) |
| Indications for Use | The MOSAIC 3D<br>laser system is<br>indicated for use in<br>dermatological<br>procedures requiring<br>the coagulation of soft<br>tissue, as well as for<br>fractional skin<br>resurfacing<br>procedures. | The MOSAIC laser<br>system is indicated for<br>use in dermatological<br>procedures requiring the<br>coagulation of soft tissue | The Fraxel 1550 nm laser is<br>indicated for use in<br>dermatological procedures<br>requiring the coagulation of<br>soft tissue, as well as for<br>skin resurfacing procedures.<br>It is also |
| Laser Type | Er:Glass Fiber laser | Er:Glass Fiber laser | Er:Glass Fiber laser |
| Wavelength | 1550 nm | 1550 nm | 1550 nm |
| Pulse Energy/MTZ | 4 - 70 mJ | 4 - 70 mJ | 4 - 70 mJ |
| Laser beam spot size | 100um | 100um | 200um |
| Density | 25 - 500 Spot/cm² | 50 - 500 Spot/cm² | UNK or 2500 spots per cm²<br>over 5 passes (per manual) |
| Pulse repetition Rate | 169.8 - 447.4 Hz | 42.3 - 588 Hz | 0-3kHz |
| Interval | 0.3s, 0.5s, 1.0s, single,<br>CW | Single | Single |
| Pattern Shapes | square, rectangle,<br>circle | Not applicable | Not applicable |
| Tip pattern / sizes | Circle: 4, 6, 8, 10,<br>12mm dia<br>Square: 6x6, 8x8,<br>10x10, 12x12, 16x16,<br>18x18, 20x20mm -<br>Rectangle: 2x12,<br>2x15, 4x12, 6x12,<br>8x12, 8x16, 8x20mm | L10×10, L6×6, L5×10,<br>H10×10 mm | Width of 15mm and 7mm |
| Use of tip | Disposable / Reusable | Reusable | Disposable |
| Cooling Mechanism | Air cooling | Air cooling | Air cooling |
| Aiming Beam | 658nm < 1mW | 658nm < 1mW | unk |
| Delivery method | Fiber | Fiber | fiber |

{7}------------------------------------------------

Image /page/7/Picture/0 description: The image shows the word "LUTRONIC" in white letters on a red background. The letters are large and bold, and the word is centered in the image. There is a small circle with an R inside of it in the upper right corner of the image. The logo is simple and easy to read.

| Type and Degree of protection against shock | Class I, Type B | Class I, Type B | Class I, Type B |
|---------------------------------------------|-----------------|-----------------|-----------------|
|---------------------------------------------|-----------------|-----------------|-----------------|

### 807.92(b)(1) NON CLINICAL TESTS SUBMITTED

- · IEC 60601-1: 2012, ed 3.1, Medical Electrical Equipment-Part 1: General Requirements for Basic Safety and Essential Performance
- · IEC 60601-1-2 Edition 4: 2014. Medical Electrical Equipment-Part 1-2: General Requirements for Basic Safety and Essential Performance-Collateral Standard: Electromagnetic Compatibility-Requirements and Tests
- · IEC 60601-2-22: 2012-10 ed 3.1, 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 Ed. 3.0 (2014) Safety Of Laser Products-Part 1: Equipment Classification and Requirements
- · Cytotoxicity per ISO 10993-5:2009
- · Skin sensitization per ISO 10993-10:2021
- Skin Irritation per ISO 10993-23:2021 ●

### 807.92(b)(2) CLINICAL TESTS SUBMITTED

A clinical study was performed to assess the effect of the laser on the tissue, healing of the tissue and potential side effects. 15 patients were treated at a range of treatment settings. Biopsies were taken the day of treatment and multiple days after treatment. Histological evaluation showed signs of coagulation formation followed by healing within 4 days. All patients saw mild anticipated side effects of erythema and edema immediately following treatment which typically resolved by end of day. There were no adverse events noted in the duration of the study.

### 807.92(b)(3) Conclusion

Based on the comparison of the technological characteristics, the specifications for the Mosaic ED are the same or a subset of the Mosaic 3D specifications. The additional tips allow the users more options in how the same energy is shaped during delivery. The new indication of fractional skin resurfacing procedures is supported by clinical testing. Also, the indication is similar to the reference device, Fraxel Dual 1550.