(60 days)
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 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.
The provided text is a 510(k) summary for the MOSAIC 3D Laser System, a surgical laser. Based on the document, here's a breakdown of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of "acceptance criteria" for performance in the typical sense of numerical thresholds for accuracy, sensitivity, or specificity. Instead, the acceptance criteria are implied through substantial equivalence to predicate devices and the demonstration of safety and effectiveness through non-clinical and clinical testing.
The primary "performance" being evaluated for this device is its ability to induce coagulation of soft tissue and perform fractional skin resurfacing.
Here’s a table summarizing relevant device characteristics and clinical findings that demonstrate its performance:
| Criterion (Implicit Acceptance) | Reported Device Performance |
|---|---|
| Safety and Essential Performance (Non-Clinical) | Device complies with: - IEC 60601-1: 2012, ed 3.1 (Basic Safety and Essential Performance) - IEC 60601-1-2 Edition 4: 2014 (Electromagnetic Compatibility) - IEC 60601-2-22: 2012-10 ed 3.1 (Particular Requirements for Laser Equipment) - IEC 60825-1 Ed. 3.0 (2014) (Safety of Laser Products) - ISO 10993-5:2009 (Cytotoxicity) - ISO 10993-10:2021 (Skin sensitization) - ISO 10993-23:2021 (Skin Irritation) |
| Effectiveness - Coagulation of soft tissue | Histological evaluation showed signs of coagulation formation. (Clinical Study) |
| Effectiveness - Tissue Healing Post-treatment | Histological evaluation showed healing within 4 days after treatment. (Clinical Study) |
| Safety - Adverse Events / Side Effects | All patients experienced mild anticipated side effects (erythema and edema) which typically resolved by end of day. No adverse events were noted during the study duration. (Clinical Study) |
| Substantial Equivalence to Predicate Device (MOSAIC HP K080932) | The MOSAIC 3D shares identical or similar technological characteristics (Laser Type: Er:Glass Fiber laser, Wavelength: 1550 nm, Pulse Energy/MTZ: 4 - 70 mJ, Laser beam spot size: 100um, Cooling Mechanism: Air cooling, Aiming Beam: 658nm < 1mW, Delivery method: Fiber, Type and Degree of protection against shock: Class I, Type B) with its predicate. The additional tips for MOSAIC 3D provide more options for energy shaping. The indications for use for coagulation of soft tissue are shared. |
| Substantial Equivalence to Reference Device (Fraxel Dual 1550 K130193) | The MOSAIC 3D shares similar technological characteristics (Laser Type: Er:Glass Fiber laser, Wavelength: 1550 nm, Pulse Energy/MTZ: 4 - 70 mJ, Cooling Mechanism: Air cooling, Delivery method: Fiber, Type and Degree of protection against shock: Class I, Type B). The new indication of fractional skin resurfacing procedures is similar to the reference device. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: 15 patients.
- Data Provenance: The document does not specify the country of origin. The study was prospective, involving actual patient treatments and subsequent biopsies.
3. 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)
- The document implies that the histological evaluation was performed by experts, but it does not specify the number of experts or their specific qualifications (e.g., dermatopathologists with certain years of experience).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- The document does not describe any formal adjudication method for establishing ground truth, such as a 2+1 or 3+1 consensus. It states "Histological evaluation showed signs..." which suggests a standard pathological assessment without detailing a multiple-expert consensus process.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- This is a laser surgical device, not an AI-assisted diagnostic tool. Therefore, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study focusing on human reader improvement with AI assistance was not done and is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This is a medical device (laser system), not a standalone algorithm. Therefore, standalone algorithm performance is not applicable. The device's performance is intrinsically tied to its operation by a human user in a clinical setting.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The ground truth for the clinical study was established primarily through pathology (histological evaluation of biopsies) and clinical observation of patient outcomes (resolution of side effects, absence of adverse events).
8. The sample size for the training set
- A "training set" is typically associated with machine learning or AI development. Since this is a physical medical device (laser system), the concept of a training set in that context is not applicable. The device's design and operating parameters would have been developed through engineering principles, pre-clinical testing, and potentially iterative design processes, not data-driven machine learning training.
9. How the ground truth for the training set was established
- As explained in point 8, the concept of a "training set" and its associated ground truth is not applicable for this type of medical device.
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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.
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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
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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 Center219, Sowon-RoDeogyang-Gu, Goyang-Si, KR 410220 |
| Phone number | 978-888-1426 |
| Fax number | N/A |
| Establishment RegistrationNumber | 1222993 |
| Name of contact person | Sarah DunneSenior Regulatory Affairs Specialist, Lutronic Aesthetic19 Fortune DriveBillerica, 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 inDermatology |
| 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) PredicateSolta 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 (ErbiumGlass) laser with a wavelength of 1550 nm. It uses Er:Glass to emit a laserbeam that is then emitted onto the treatment area via the handpiece connectedto the optical fiber of the main body of the system. It is comprised of a mainbody, a handpiece connected to an optical fiber, a tip, a footswitch, andgoggles for laser protection. The laser beam is emitted onto the area to betreated through the tips (roller tip, sapphire tip, comb tip, pill tip) connectedto the handpiece. | |
| When the beam contacts tissue the laser beam emits many separatemicrobeams and creates a microscopic treatment zone (MTZ). Thermalcoagulation is then induced in the dermis using the principle of fractionalphoto thermolysis, sparing the normal skin tissue surrounding the MTZ area.When the laser beam is emitted onto skin tissue, the energy of the beam isabsorbed by specific tissues or chromophores such as water and is thenconverted into thermal energy, causing thermal damage to produce atherapeutic effect.The MOSAIC 3D Laser System is controlled via a LCD touchscreen guideduser interface in the front of the device, which is used to easily configureoptimal treatment parameters and check parameters set in the device in thecurrent system mode. | |
| 807.92(a)(5) Intended use of the device | |
| Indications for use | The MOSAIC 3D Laser System is indicated for use in dermatologicalprocedures requiring the coagulation of soft tissue, as well as for fractionalskin resurfacing procedures. |
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| 807.92(a)(6) Summary of the technological characteristics of the device compared to the predicate | |||
|---|---|---|---|
| MOSAIC 3D | MOSAIC HPK080932 | Fraxel Dual 1550K130193 (reference) | |
| Indications for Use | The MOSAIC 3Dlaser system isindicated for use indermatologicalprocedures requiringthe coagulation of softtissue, as well as forfractional skinresurfacingprocedures. | The MOSAIC lasersystem is indicated foruse in dermatologicalprocedures requiring thecoagulation of soft tissue | The Fraxel 1550 nm laser isindicated for use indermatological proceduresrequiring the coagulation ofsoft tissue, as well as forskin 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 cm²over 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 diaSquare: 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 < 1mW | 658nm < 1mW | unk |
| Delivery method | Fiber | Fiber | fiber |
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| 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.
§ 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.