(154 days)
The MOSAIC Laser System is indicated for use in dermatological procedures requiring the coagulation of soft tissue.
The MOSAIC Laser System consists of a self-contained console, an optical fiber delivery system and a footswitch. The MOSAIC produces a beam of coherent infrared (1550 nm) light. The physician can optimize the effect for different applications by controlling the power of the laser pulse and using a different handpiece tip (5 mm, 6 mm, 8 mm, and 10 mm). The system console is the heart of the MOSAIC Laser System and contains the optical system (Er-GLASS Fiber Laser Module), Touch LCD, handpiece, system control module with an embedded processor, and power supply module. The main console also includes a key switch used to turn the power on and off, an emergency stop push button that quickly de-energizes the system in emergency situations, and the Touch LCD.
This document (K070392) is a 510(k) summary for the Lutronic Corporation MOSAIC Laser System. It focuses on establishing substantial equivalence to predicate devices for its intended use in dermatological procedures requiring soft tissue coagulation.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device in histological response. | "Human and animal performance data was provided which documented that the histological response to the MOSAIC was substantially equivalent to the predicate device." |
| Safety and effectiveness for dermatological procedures requiring soft tissue coagulation. | Indicated for dermatological procedures requiring the coagulation of soft tissue. |
Explanation of Implied Criteria:
The FDA 510(k) pathway is primarily about demonstrating substantial equivalence to a legally marketed predicate device. Therefore, the "acceptance criteria" are implicitly tied to showing that the new device performs as safely and effectively as the predicate, especially regarding its mechanism of action and biological response. In this case, the key criterion is the histological response.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document states: "Human and animal performance data was provided..."
- Sample Size for Test Set: The specific sample sizes for human and animal subjects are not provided in this summary.
- Data Provenance:
- Country of Origin: Not explicitly stated for the test data, but the submitter (Lutronic Corporation) is based in the Republic of Korea. It's plausible the data originates from there or associated research facilities.
- Retrospective or Prospective: Not explicitly stated.
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):
This information is not provided in the document. For histological analysis, it would typically involve pathologists, but their number and qualifications are not disclosed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided in the document.
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 not applicable to this submission. The MOSAIC Laser System is a medical device (laser system), not an AI/software-as-a-medical-device (SaMD) or diagnostic imaging system that would involve human readers interpreting data alongside or without AI assistance. The study focuses on the histological response of tissue to the laser.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable as it's not an AI algorithm. The device performance relates to the biophysical interaction of laser energy with tissue.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth used appears to be histological analysis/pathology. The document explicitly mentions "histological response" as the primary performance metric.
8. The sample size for the training set:
This is not applicable as it's not an AI/machine learning device that requires a training set. The "training" in this context would refer to device design, engineering, and preclinical testing, rather than an AI training set.
9. How the ground truth for the training set was established:
This is not applicable for the same reason as point 8.
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510(k) Summary for the Lutronic Corporation MOSAIC Laser System
This 510(k) Summary is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.
1. General Information
| Submitter: | Lutronic Corporation#403-2,3,4, Ilsan Technotown1141-1 Baeksok-Dong, Ilsan-GuGoyang-Si, Gyeonggi-Do, 410-722Republic of Korea |
|---|---|
| Contact Person: | Maureen O'ConnellO'Connell Regulatory Consultants, Inc.5 Timber LaneNorth Reading, MA 01864Telephone: 978-207-1245Fax: 978-207-1246 |
| Summary Preparation Date: | July 11, 2007 |
| Names: | |
| Device Name: | MOSAIC Laser System |
Classification Name:
Laser Instrument, Surgical, Powered Product Code: GEX Panel : General & Plastic Surgery
3. Predicate Devices
The MOSAIC Laser System is substantially equivalent to a combination of the Fraxel SR Laser System (K053047) and the Fraxel II SR Laser System and Accessories (K060310).
4. Device Description
The MOSAIC Laser System consists of a self-contained console, an optical fiber delivery system and a footswitch. The MOSAIC produces a beam of coherent infrared (1550 nm) light. The physician can optimize the effect for different applications by controlling the power of the laser pulse and using a different handpiece tip (5 mm, 6 mm, 8 mm, and 10 mm).
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The system console is the heart of the MOSAIC Laser System and contains the optical system (Er-GLASS Fiber Laser Module), Touch LCD, handpiece, system control module with an embedded processor, and power supply module. The main console also includes a key switch used to turn the power on and off, an emergency stop push button that quickly de-energizes the system in emergency situations, and the Touch LCD.
5. Indications for Use
The MOSAIC Laser System is indicated for use in dermatological procedures requiring the coagulation of soft tissue.
6. Performance Data
Human and animal performance data was provided which documented that the histological response to the MOSAIC was substantially equivalent to the predicate device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring three abstract human profiles facing to the right, with flowing lines suggesting movement or connection.
JUL 1 3 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
O'Connell Regulatory Consultants, Inc. % Maureen O'Connell Regulatory Consultant 5 Timber Lane North Reading, Massachusetts 01864
Re: K070392
Trade/Device Name: MOSAIC Laser System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general And plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: July 2, 2007 Received: July 3, 2007
Dear Ms. 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 (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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
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); good manufacturing practice requirements as set
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Page 2 - Ms. Maureen O'Connell
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050, This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Mello
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): __ . .
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use:
The MOSAIC Laser System is indicated for dermatological procedures requiring the coagulation of soft tissue.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over The Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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(Division Sign-Off) Division of General, Restorative, and Neurological Devices
*100(k) Number K07032
§ 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.