(196 days)
Not Found
No
The summary describes a laser system with different operating modes and adjustable parameters controlled by the physician. There is no mention of AI, ML, or any automated decision-making or analysis based on data or imaging.
Yes
The device is indicated for the treatment of various dermatological conditions such as wrinkles, rhytides, furrows, fine lines, textural irregularities, pigmented lesions, and vascular dyschromia, which constitutes therapeutic use.
No
The device description and intended use clearly state that the eCO2 Laser System is used for "ablation (removal), resurfacing and coagulation of soft tissue" and for the "treatment of wrinkles," indicating therapeutic rather than diagnostic purposes.
No
The device description clearly outlines hardware components such as a console, articulated arm, scanner handpiece, and footswitch, indicating it is a physical laser system, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "dermatological procedures requiring ablation (removal), resurfacing and coagulation of soft tissue." This describes a therapeutic or surgical procedure performed directly on the patient's body.
- Device Description: The description details a laser system that produces a beam of light to interact with tissue water, causing vaporization. This is a physical interaction with the tissue, not an analysis of a sample taken from the body.
- Lack of IVD Characteristics: An IVD device is designed to examine specimens (like blood, urine, tissue samples) taken from the human body to provide information for diagnosis, monitoring, or screening. The provided information does not mention any such analysis of samples.
Therefore, the eCO2 Laser System is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The eCO2 Laser System is indicated for use in dermatological procedures requiring ablation (removal), resurfacing and coagulation of soft tissue. Additionally, the 120 micron and 300 micron spot sizes are used in the treatment of wrinkles; rhytides, furrows, fine lines, textural irregularities, pigmented lesions and vascular dyschromia.
Product codes
GEX
Device Description
The eCO2 Laser System consists of a self-contained console, an articulated arm delivery system with scanner handpiece and a footswitch. The 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 eCO2 Laser System utilizes a CO2 RF module 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
Soft tissue, skin (for wrinkles, rhytides, furrows, fine lines, textural irregularities, pigmented lesions and vascular dyschromia)
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)
K080496, K080915, K063001, K022060, K030147, 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.
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OCT 3 0 2009
510(k) Summary for the Lutronic Corporation 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:
- Names
Device Name:
Classification Name:
eCO2 Laser System
October 26, 2009
Laser Instrument, Surgical, Powered Product Code: GEX Panel: General & Plastic Surgery
3. Predicate Devices
The eCO2 is a modification of the eCO2 cleared in K080496. The indications for use are exactly the same as the cleared eCO2. Additionally, the eCO2 is substantially equivalent to the Reliant Technologies, Inc. Fraxel III SR Laser System (Fraxel re:pair) and Accessorics (K080915); the Lasering SLIM Evolution Family of CO2 Lasers with Mixto SX Scanner (K063001); Lumenis, Inc. Active FX and Deep FX UltraPulse Encore Carbon Dioxide Surgical Laser and Deliverv Device Accessories (K022060 and K030147); and the Cynosure, Inc. Smart CO2 (K031224).
1
4. Device Description
The eCO2 Laser System consists of a self-contained console, an articulated arm delivery system with scanner handpiece and a footswitch. The 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 eCO2 Laser System utilizes a CO2 RF module 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 eCO2 Laser System is indicated for use in dermatological procedures requiring ablation (removal), resurfacing and coagulation of soft tissue. Additionally, the 120 micron and 300 micron spot sizes are used in the treatment of wrinkles; rhytides, furrows, fine lines, textural irregularities, pigmented lesions and vascular dyschromia.
- Performance Data None presented.
2
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Lutronic Corporation % O'Connell Regulatory Consultants, Inc. Ms. Maureen O'Connell 5 Timber Lane North Reading, Massachusetts 01864
OCT 3 0 2009
Re: K091115
Trade/Device Name: 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: Class II Product Code: GEX Dated: September 30, 2009 Received: October 1, 2009
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 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); medical device reporting of medical device-related adverse events) (21 CFR 803); 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,
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
For P.S. Nermile
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| Indications for Use |
|---|
| ---------------------------- |
| 510(k) Number (if known): | K 091115 |
|---|---|
| --------------------------- | ---------- |
Device Name:
Indications for Use:
The eCO2 Laser System is indicated for use in dermatological procedures requiring ablation (removal), resurfacing and coagulation of soft tissue. Additionally, the 120 micron and 300 micron spot sizes are used in the treatment of wrinkles; 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)
Neil kp Spher Frxn
Page 1 of 1
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K091115