(60 days)
No
The description focuses on the laser technology and user interface for setting parameters, with no mention of AI or ML for image analysis, treatment planning, or other functions.
Yes
The device is described as causing "thermal damage to produce a therapeutic effect," indicating its use for treatment.
No
The device is described as a laser system used for dermatological procedures requiring the coagulation of soft tissue and fractional skin resurfacing, which are treatment functions, not diagnostic ones.
No
The device description clearly outlines hardware components including a laser, handpiece, optical fiber, tips, footswitch, and goggles. While it has a software interface, it is integral to a physical laser system.
Based on the provided information, the MOSAIC 3D Laser System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for "dermatological procedures requiring the coagulation of soft tissue, as well as for fractional skin resurfacing procedures." This describes a therapeutic or cosmetic procedure performed directly on a patient's body.
- Device Description: The description details a laser system that emits a beam to interact with tissue. This is a physical intervention on the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue samples) outside of the body to provide information for diagnosis, monitoring, or screening. The MOSAIC 3D Laser System does not perform any such analysis of specimens.
Therefore, the MOSAIC 3D Laser System is a medical device used for direct treatment of patients, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
ONG, GEX
Device Description
The MOSAIC 3D Laser System is a non-ablative fractional Er:Glass (Erbium Glass) laser with a wavelength of 1550 nm. It uses Er:Glass to emit a laser beam that is then emitted onto the treatment area via the handpiece connected to the optical fiber of the main body of the system. It is comprised of a main body, a handpiece connected to an optical fiber, a tip, a footswitch, and goggles for laser protection. The laser beam is emitted onto the area to be treated through the tips (roller tip, sapphire tip, comb tip, pill tip) connected to the handpiece.
When the beam contacts tissue the laser beam emits many separate microbeams and creates a microscopic treatment zone (MTZ). Thermal coagulation is then induced in the dermis using the principle of fractional photo thermolysis, sparing the normal skin tissue surrounding the MTZ area. When the laser beam is emitted onto skin tissue, the energy of the beam is absorbed by specific tissues or chromophores such as water and is then converted into thermal energy, causing thermal damage to produce a therapeutic effect.
The MOSAIC 3D Laser System is controlled via a LCD touchscreen guided user interface in the front of the device, which is used to easily configure optimal treatment parameters and check parameters set in the device in the current system mode.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue (dermatological procedures)
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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.
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
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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)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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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 |
| 219, Sowon-Ro | |
| Deogyang-Gu, Goyang-Si, KR 410220 | |
| Phone number | 978-888-1426 |
| Fax number | N/A |
| Establishment Registration | |
| Number | 1222993 |
| Name of contact person | Sarah Dunne |
| Senior Regulatory Affairs Specialist, Lutronic Aesthetic | |
| 19 Fortune Drive | |
| 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 |
| 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 | |
| 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 | |
| Glass) laser with a wavelength of 1550 nm. It uses Er:Glass to emit a laser | |
| beam that is then emitted onto the treatment area via the handpiece connected | |
| to the optical fiber of the main body of the system. It is comprised of a main | |
| body, a handpiece connected to an optical fiber, a tip, a footswitch, and | |
| goggles for laser protection. The laser beam is emitted onto the area to be | |
| treated through the tips (roller tip, sapphire tip, comb tip, pill tip) connected | |
| to the handpiece. | |
| When the beam contacts tissue the laser beam emits many separate | |
| microbeams and creates a microscopic treatment zone (MTZ). Thermal | |
| coagulation is then induced in the dermis using the principle of fractional | |
| photo thermolysis, sparing the normal skin tissue surrounding the MTZ area. | |
| When the laser beam is emitted onto skin tissue, the energy of the beam is | |
| absorbed by specific tissues or chromophores such as water and is then | |
| converted into thermal energy, causing thermal damage to produce a | |
| therapeutic effect. | |
| The MOSAIC 3D Laser System is controlled via a LCD touchscreen guided | |
| user interface in the front of the device, which is used to easily configure | |
| optimal treatment parameters and check parameters set in the device in the | |
| 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 |
| procedures requiring the coagulation of soft tissue, as well as for fractional | |
| skin resurfacing procedures. |
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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.
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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 | ||
| K080932 | Fraxel Dual 1550 | ||
| K130193 (reference) | |||
| Indications for 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. | The MOSAIC laser | ||
| system is indicated for | |||
| use in dermatological | |||
| procedures requiring the | |||
| coagulation of soft tissue | The Fraxel 1550 nm laser is | ||
| indicated for use in | |||
| dermatological procedures | |||
| requiring the coagulation of | |||
| soft tissue, as well as for | |||
| skin resurfacing procedures. | |||
| 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 |
| 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, | ||
| CW | Single | Single | |
| Pattern Shapes | square, rectangle, | ||
| circle | Not applicable | Not applicable | |
| Tip pattern / sizes | Circle: 4, 6, 8, 10, | ||
| 12mm dia | |||
| Square: 6x6, 8x8, | |||
| 10x10, 12x12, 16x16, | |||
| 18x18, 20x20mm - | |||
| Rectangle: 2x12, | |||
| 2x15, 4x12, 6x12, | |||
| 8x12, 8x16, 8x20mm | L10×10, L6×6, L5×10, | ||
| 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 |