(90 days)
The Forona Novalis R Ruby Laser System for removal of unwanted body hair.
The Fotona Novalis R system is based on Ruby laser technology. Within the system, an optical cavity contains the Ruby crystal, which is activated by means of the use of flashlamps. Pulsed laser cacrev is provided through an optical fiber beam delivery system. While observing and directing, the aiming beam (diode laser, 635 nm), the treatment beam is administrated by the physician through a footwitch. The laser is used in non-contact mode.
The System is capable of emitting up to 25 J of pulsed light at 694 nm This light has a pulsewidth which varies in the range from I to 4 ms and can be adjusted by the user. The spot sizes from 8 to 14 mm can be chosen on the handpiece and are detected by the microprocessor controller. The corresponding energy fluence to tissue is displayed on a screen. The maximum fluence of 503/cm² can be achieved by selecting the highest out energy and the smallest spot size.
The Novalis R system is designed with 5 major sub-systems:
a) A high voltage power supply which converts and rectifies the a.c. mains current to provide regulated power for the tlashlamp simmer current and main triggering mille
b) A cooling system consisting of an internal water flow circuit together with warer-to-air heat exchanger.
c) An ruby laser rod, capable of generating 25 J optical pulses at a frequency up to 2 Hz.
d) An optical delivery system, interfacing the encrgy from the lascr to the patient via an optical fiber and a handpiccc.
a) The microprocessor based controller which regulates the functions of the laser and allows parameter selection by the user.
The provided text is a 510(k) summary for the Fotona Novalis R Ruby Laser System, seeking clearance for marketing based on substantial equivalence to predicate devices. It describes the device's technology and intended use. However, it does not contain information about specific acceptance criteria, a study proving device performance against those criteria, or details regarding sample sizes, ground truth establishment, or expert involvement in a typical medical device performance study.
Therefore, I cannot fulfill your request for this specific document. The information you are asking for (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) is characteristic of a clinical performance study or validation study which is not present in this summary.
This document focuses on demonstrating substantial equivalence to already cleared devices, rather than presenting a de novo performance study with specific acceptance criteria and detailed outcomes. It states that "no new questions of Safety or Effectiveness raised by the introduction of this device."
To reiterate, the requested information (acceptance criteria and detailed study data) is not available in the provided text.
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AUG 10 1999 Summary of Safety and Effectiveness Data Appendix E ・・
General Information and Description
The Fotona Novalis R system is based on Ruby laser technology. Within the system, an optical cavity contains the Ruby crystal, which is activated by means of the use of flashlamps. Pulsed laser cacrev is provided through an optical fiber beam delivery system. While observing and directing, the aiming beam (diode laser, 635 nm), the treatment beam is administrated by the physician through a footwitch. The laser is used in non-contact mode.
The System is capable of emitting up to 25 J of pulsed light at 694 nm This light has a pulsewidth which varies in the range from I to 4 ms and can be adjusted by the user. The spot sizes from 8 to 14 mm can be chosen on the handpiece and are detected by the microprocessor controller. The corresponding energy fluence to tissue is displayed on a screen. The maximum fluence of 503/cm² can be achieved by selecting the highest out energy and the smallest spot size.
The laser is intended to be used for removal of unwanted body hair.
The Novalis R system is designed with 5 major sub-systems:
a) A high voltage power supply which converts and rectifies the a.c. mains current to provide regulated power for the tlashlamp simmer current and main triggering mille
b) A cooling system consisting of an internal water flow circuit together with warer-to-air heat exchanger.
c) An ruby laser rod, capable of generating 25 J optical pulses at a frequency up to 2 Hz.
d) An optical delivery system, interfacing the encrgy from the lascr to the patient via an optical fiber and a handpiccc.
a) The microprocessor based controller which regulates the functions of the laser and allows parameter selection by the user.
Accessories available for use with Fotona Novalis K
- · Fotona Novalis Er: YAG Laser
- · CSC Device (Controlled Selective Cooling Device) or Cooling Gel or Cold Packs
Summary of Substantial Equivalcncc
Fotona believes that its Novalis R system is substantially equivalent to the Palomar EpiLaser Normal Mode Ruby Laser, Sharplan EpiTouch Ruby Laser and to the other previously FDA cleared Ruby lasers.
The predicate devices are cleared for removal of unwanted body hair. They therefore have the same Intended Use as the Fotona Novalis R.
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Technologically, the predicate devices have identical characteristics to the Novalis R, all these devices comprising a flashlamp pumped ruby laser rod generating light at a wavelength of 694 nm, which is subsequently delivered to the patient via the fiber-optic delivery and handpiece.
The predicate devices have the ability to deliver laser energy at 694 nm, maximum fluence to tissue of 40J/cm2 and are used with different skin cooling techniques. These characteristics are very similar to the Fotona Novalis R Ruby Laser System.
The risk and benefits for the Fotona Novalis R are comparable to the risk and benefits of the prodicate devices when used for the same application.
It is therefore believed that there are no new questions of Safety or Effectiveness raised by the introduction of this device.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, overlaid on a human profile. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 10 1999
Ms. Mojca Valjavec, Dipl. Eng. Product Manager Lasers Division Fontona d.d. Stegne 7, 1210 Ljubljana, Slovenia
K991632 Re:
K991634 Trade Name: Fontona NovalisR Ruby Laser System Fontona Novalis Er:YAG Laser System Regulatory Class: II Product Code: GEX Dated: May 3, 1999 Received: May 12, 1999
Dear Ms. Valjavec:
We have reviewed your Section 510(k) notification of intent to market the devices referenced above, and we have determined the devices are substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the devices, subject to the general control provisions of the Act. The general control provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General Regulation (21 CFR Part 820), and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your devices in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Ms. Mojca Valjavec, Dipl. Eng.
This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA, finding of substantial equivalence of your devices to legally marketed predicate devices. results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your devices, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled. "Misbranding by reference to premarket notification (21 CFR 807.97)." Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html."
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
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APPENDIX F
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K991634
Device Name:
FOTONA NOVALIS R RUBY LASER SYSTEM
Indications For Lise:
The Forona Novalis R Ruby Laser System for removal of unwanted body hair.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Countor Usc
pateylo
(Division Sign-Off)
n of Gene 510(k) Number
§ 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.