(434 days)
Not Found
No
The description focuses on the physical properties and delivery mechanism of a CO2 laser, with no mention of AI or ML terms, image processing, or data-driven algorithms for analysis or control.
Yes
The device is used for dermatological procedures requiring ablation, resurfacing, or coagulation of soft tissue, which are therapeutic interventions.
No
The device is a therapeutic laser system used for dermatological procedures involving ablation, resurfacing, or coagulation of soft tissue. It is not designed to diagnose diseases or conditions.
No
The device description clearly describes a physical laser system with hardware components like an articulated arm and scanner, not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This testing happens outside the body (in vitro).
- NaturaLase CO2 Laser System Function: The description clearly states the NaturaLase CO2 Laser System is used for "dermatological procedures requiring ablation (removal), resurfacing or coagulation of soft tissue." This is a therapeutic procedure performed on the body, not a diagnostic test performed on a specimen.
The device is a therapeutic laser system used for treating skin conditions, not for diagnosing them through laboratory testing of samples.
N/A
Intended Use / Indications for Use
The NaturaLase CO2 Laser System is indicated for use in dermatological procedures requiring ablation (removal), resurfacing or coagulation of soft tissue.
Product codes
ONG
Device Description
The NaturaLase CO2 is an RF excited CO2 laser. The laser energy is delivered through an articulated arm and with a scanner that distributes the laser energy on the skin in a controlled way with uniform distribution. The scanner design allows the system to ablate small micro spots of tissue. The system has the ability to deliver micro spots with a size of 120 microns and up to 45 mJ of optical energy per micro spot.
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
Histology data was collected to demonstrate the performance of the laser. The study included laser treatment of human skin to verify the healing rate and the characteristics of the micro spot at various energy settings. Punch biopsies were used to measure spot size, treatment depth and the healing process over a three week period. The wounds and the healing process showed an excellent correlation with literature and with the control laser.
Summary of Performance Studies
Histology data was collected to demonstrate the performance of the laser. The study included laser treatment of human skin to verify the healing rate and the characteristics of the micro spot at various energy settings. Punch biopsies were used to measure spot size, treatment depth and the healing process over a three week period. The wounds and the healing process showed an excellent correlation with literature and with the control laser.
Key Metrics
Not Found
Predicate Device(s)
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
0333 . Pg 1 of
Focus Medical NaturaLase CO2 510(k) Submission
510(K) SUMMARY 5.
ﺔ ﻳ
APR 1 2 2012
| Applicant: | Focus Medical
23 Francis J. Clarke Circle
Bethel, CT 06801
203-730-8885 |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer: | Focus Medical
23 Francis J. Clarke Circle
Bethel, CT 06801 |
| Contact Person: | Mr. John B. Lee, Jr.
President
Focus Medical |
| Name of the Device: | NaturaLase CO2 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 |
| Predicate Device: | Lutronic Mosaic eCO2 Laser System (K080496) |
| Device Description: | The NaturaLase CO2 is an RF excited CO2 laser. The laser energy is
delivered through an articulated arm and with a scanner that distributes
the laser energy on the skin in a controlled way with uniform distribution.
The scanner design allows the system to ablate small micro spots of
tissue. The system has the ability to deliver micro spots with a size of 120
microns and up to 45 mJ of optical energy per micro spot. |
| Indications for Use: | The NaturaLase CO2 Laser System is indicated for use in
dermatological procedures requiring ablation (removal), resurfacing
or coagulation of soft tissue. |
| Substantial Equivalence: | The NaturaLase CO2 has the same intended use as the predicate device-
Lutronic Mosaic eCO2 Laser System (K080496). It uses the same
fundamental technology as the predicate device. Both systems use
similar RF excited CO2 laser tubes with the energy delivered through an
articulated arm and a scanner. Both use a 120 micron micro spot and
have various scanner patterns that deliver ablative fractional resurfacing. |
| Histology Data: | Histology data was collected to demonstrate the performance of the laser.
The study included laser treatment of human skin to verify the healing rate
and the characteristics of the micro spot at various energy settings.
Punch biopsies were used to measure spot size, treatment depth and the
healing process over a three week period. The wounds and the healing
process showed an excellent correlation with literature and with the
control laser. |
| Conclusion: | The specifications, indications for use and performance of the NaturaLase
CO2 Laser is substantially equivalent to the legally marketed predicate
device. Histology data confirmed the treatment parameters and the safety
and effectiveness of the laser. It raises no new issues of safety and
effectiveness and should be approved for marketing under the general
controls provisions of the Federal Food, Drug, and Cosmetic Act. |
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
APR 1 2 2012
Focus Medical % Mr. John B. Lee, Jr. President 23 Francis J. Clarke Circle Bethel. Connecticut 06801
Re: K110333
Trade/Device Name: NaturaLase CO2 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: ONG Dated: March 20, 2012 Received: April 3, 2012
Dear Mr. Lee:
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 piemarket 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. 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.
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
2
Page 2 - Mr. John B. Lee, Jr.
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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/CDRH0ffices/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/MedicalDevices/Safety/ReportaProblem/default.htm 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/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
iely yours,
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Focus Medical NaturaLase CO2 510(k) Submission
110333 pg1. of 1
INDICATIONS FOR USE STATEMENT 4.
Intended Use Statement
The NaturaLase CO2 Laser System is indicated for use in dermatological procedures requiring ablation (removal), resurfacing or coagulation of soft tissue.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR Over-The-Counter Use (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) The
Neil R. Doyle for nxm
(Division Sign-Off) (Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K110333
Confidential