(136 days)
Not Found
No
The summary describes a standard CO2 laser system with different operating modes and adjustable parameters controlled by the physician. There is no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device is used for treating various medical conditions such as wrinkles, rhytides, furrows, fine lines, textural irregularities, pigmented lesions, and vascular dyschromia, which indicates a therapeutic purpose.
No
Explanation: The device description states its use in dermatological procedures for ablation, resurfacing, and coagulation of soft tissue, as well as treatment of various skin conditions, all of which are treatment-oriented applications. There is no mention of analysis, diagnosis, or detection of disease.
No
The device description clearly outlines hardware components such as a console, articulated arm, scanner handpiece, footswitch, and a CO2 tube, indicating it is a physical laser system, not software only.
Based on the provided information, the MOSAIC eCO2 device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "dermatological procedures requiring ablation (removal), resurfacing and coagulation of soft tissue." This describes a direct treatment on the patient's body.
- Device Description: The description details a laser system that produces a beam of light to interact with tissue. This is a physical intervention, not a test performed on samples taken from the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. IVDs are used to examine specimens in vitro (outside the body) to provide information about a person's health.
The MOSAIC eCO2 is a therapeutic medical device used for surgical and cosmetic procedures on the skin.
N/A
Intended Use / Indications for Use
The MOSAIC eCO2 is indicated for use in dermatological procedures requiring ablation (removal), resurfacing and coagulation of soft tissue. Treatment of wrinkles, rhytides, furrows, fine lines, textural irregularities, pigmented lesions and vascular dyschromia.
Product codes
GEX
Device Description
The MOSAIC eCO2 Laser System consists of a self-contained console, an articulated arm delivery system with scanner handpiece and a footswitch. The MOSAIC eCO2 produces a beam of coherent infrared light (10.6um) and has two operation modes (Static mode and Dynamic Mode). The laser works in medical applications because 10.6um is near the peak of tissue water absorption. When the water in the tissue absorbs the laser energy, it heats up. This heating causes instantaneous vaporization of the target tissue.
The MOSAIC eCO2 Laser System utilizes a CO2 tube to generate a laser beam with a wavelength of 10.6 um and uses a scanner handpiece. The physician can optimize the effect for different applications by controlling the power of the laser pulse and using a different scan pattern.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
None presented.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K022060, K933918, K030147, K071051, K031224
Reference Device(s)
Not Found
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.
0
510(k) Summary for the 'JUL - 7 2008 Lutronic Corporation MOSAIC eCO2 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 Technotown
1141-1 Baeksok-Dong, Ilsan-Gu
Goyang-Si, Gyeonggi-Do, 410-722
Republic of Korea |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Maureen O'Connell
O'Connell Regulatory Consultants, Inc.
5 Timber Lane
North Reading, MA 01864
Telephone: 978-207-1245
Fax: 978-824-2541 |
| Summary Preparation Date: | July 1, 2008 |
2. Names
MOSAIC eCO2 Laser System (Trade Name: MOSAIC eCO2) Device Name:
Classification Name:
Laser Instrument, Surgical, Powered Product Code: GEX Panel: General & Plastic Surgery
3. Predicate Devices
The MOSAIC eCO2 is substantially equivalent to the predicate devices, including the Lumenis, Inc. (Lumenis UltraPulse Encore Carbon Dioxide Surgical Laser and Delivery Device Accessories) (K022060); the Sharplan Lasers, Inc. Model 1080 CO2 Surgical Laser System (K933918); the Lumenis, Inc. Modified Lumenis Family of UltraPulse SurgiTouch CO2 Laser Systems (K030147); the Reliant Technologies, Inc. Fraxel III SR Laser System (Fraxel re:pair) and Accessories (K071051); and the Cynosure, Inc. Smart CO2 (K031224).
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4. Device Description
The MOSAIC eCO2 Laser System consists of a self-contained console, an articulated arm delivery system with scanner handpiece and a footswitch. The MOSAIC eCO2 produces a beam of coherent infrared light (10.6um) and has two operation modes (Static mode and Dynamic Mode). The laser works in medical applications because 10.6um is near the peak of tissue water absorption. When the water in the tissue absorbs the laser energy, it heats up. This heating causes instantaneous vaporization of the target tissue.
The MOSAIC eCO2 Laser System utilizes a CO2 tube to generate a laser beam with a wavelength of 10.6 um and uses a scanner handpiece. The physician can optimize the effect for different applications by controlling the power of the laser pulse and using a different scan pattern.
5. Indications for Use
The MOSAIC eCO2 is indicated for use in dermatological procedures requiring ablation (removal), resurfacing and coagulation of soft tissue. Treatment of wrinkles, rhytides, furrows, fine lines, textural irregularities, pigmented lesions and vascular dyschromia.
-
- Performance Data
None presented.
- Performance Data
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The text is in all caps and is evenly spaced around the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 7 2008
Lutronic Corporation % O'Connell Regulatory Consultants Ms. Maureen O'Connell 5 Timber Lane North Reading, Massachusetts 01864
Re: K080496 Trade/Device Name: MOSAIC eCO2 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: June 16, 2008 Received: June 17, 2008
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. Iisting 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Prestmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities mader 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 M. Mcllveen
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): ____________________________________________________________________________________________________________________________________________________ K080496
Device Name: _ _ _ _ _ MQSAIC eCO2 Laser System ______________________________________________________________________________________________________________________________
Indications for Use:
The MOSAIC eCO2 is indicated for use in dermatological procedures requiring ablation (removal), resurfacing and coagulation of soft tissue. Treatment of wrinkles; rhytides, furrows, fine lines, textural irregularities, pigmented lesions and vascular dyschromia.
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)
Page 1 of 1
Varlare Buessy
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
510(k) Number K050496