(45 days)
The Candela Fluorescent Pulsed Light System is indicated for the following uses:
Hair removal in all skin types to the Fitzpatrick scale. Permanent Hair Reduction.
Treatment of Vascular Lesions
Treatment of Inflammatory Acne (acne vulgaris)
Treatment of Benign Pigmented Epidermal and Cutaneous Lesions including warts, scars and striae.
The Candela Fluorescent Pulsed Light System is designed for selective photothermolysis in aesthetic treatments. The technology is based on a unique combination of patented fluorescent filter technology, selected spectrums of light source emission; pulse forming and sapphire based skin cooling system. It operates through creation of a directed incoherent light beam of spectrally balanced light. The light is spectrally filtered to remove the shorter wavelength portions (UV) most likely to cause harm to the skin. A sapphire crystal light guide is used to transport the resultant longer wavelength light to a laser-dye impregnated polymer filter sheet, which absorbs the part of the lamp light spectrum below it's emission and emits the selected wavelength band (417- 1200 nm) to 615 - 1200 nm, and non fluorescent 650 nm - 1200 nm and 850 - 1200 nm.
A liquid-to-air cooling system, including a fluid pump, fluid reservoir, deionization filter, interlocks and forced convection liquid-to-air heat exchanger and a water to water ThermoElectrical cooler is used to maintain the hand piece components at the proper temperature. The electronic components of the system include multiple safety features to protect both the user and patient, and the pulsed-light system itself.
A microprocessor based system controller is used to monitor and direct all system functions. Users of the Candela Fluorescent Pulsed Light System select parameters such as desired energy density (fluence) level and filter wavelength and monitor operation via electronic controls and a display panel. The control panel is also used to enable or disable the triggering of the Candela Fluorescent Pulsed Light System, and to obtain feedback from the system, such as the number of pulses delivered or spot size selected. The Candela Fluorescent Pulsed Light System supports 40mm x 20mm, 20mm x 20mm, 10mm x 20mm, 7mm x 15mm, 7mm x 7mm.
I am sorry, but based on the provided document, I cannot fulfill your request for detailed information regarding acceptance criteria and a study proving device performance in the way you've outlined. This document is a 510(k) summary for a Candela Fluorescent Pulsed Light System (K063800), which focuses on demonstrating substantial equivalence to predicate devices rather than directly presenting the results of a primary clinical study with specific performance metrics against acceptance criteria.
The document states: "The Candela Fluorescent Pulsed Light System is substantial equivalent to the currently legally marketed Luxsano AB OmniLight Fluorescent Pulsed Light System, K032191 and the Palomar Medical Technologies, Inc. StarLux Pulsed Light System, K041086 predicate devices in intended use and technological features and therefore the risks and benefits are comparable to the predicate devices."
This means the FDA cleared the device based on its similarity to previously cleared devices, not necessarily on a new clinical study.
Therefore, I cannot provide:
- A table of acceptance criteria and the reported device performance: This level of detail about specific performance metrics and acceptance thresholds for a new clinical study is not present.
- Sample size used for the test set and the data provenance: No new test set is described or analyzed in this document.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No mention of expert review or ground truth establishment for a new study.
- Adjudication method for the test set: Not applicable as no new test set is presented.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No MRMC study is mentioned.
- If a standalone performance study was done: The document does not describe a standalone study. Instead, it relies on substantial equivalence.
- The type of ground truth used: Not applicable.
- The sample size for the training set: No training set for an AI/algorithm is mentioned, as this device is not an AI-based system.
- How the ground truth for the training set was established: Not applicable.
The document's purpose is to establish substantial equivalence based on functional features, intended use, and technological features compared to existing devices. It does not contain the detailed reporting of a clinical study that would answer your specific questions about acceptance criteria and performance data from a new study.
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Image /page/0/Picture/0 description: The image shows the logo for Candela. The logo consists of a stylized flame on the left and the word "CANDELA" on the right. The flame is black on the left side and has horizontal lines on the right side. The word "CANDELA" is in a simple, sans-serif font.
510(k) Summary
This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990. The contents of the 510(k) summary have been provided in conformance with 21 CFR $807.92.
Submitter Information
| Company Name: | Candela Corporation | FEB 05 2007 |
|---|---|---|
| Company Address: | 530 Boston Post Road | |
| Wayland, MA 01778 | ||
| Company Phone: | 508-358-7400 | |
| Company Facsimile: | 508-358-5602 | |
| Contact Person: | Mr. Jeffrey Roberts | |
| Manager, Regulatory Affairs | ||
| Date summary Prepared: | 12/14/06 |
Device Identification
| Device Trade/Proprietary Name: | Candela Fluorescent Pulsed Light System |
|---|---|
| Common Name: | Fluorescent Pulsed Light System |
| Classification Name: | Laser Surgical Instrument, for use in General and PlasticSurgery and Dermatology |
| Classification Regulation: | 21 CFR § 878.4810 |
| Device Classification: | II |
Identification of Predicate Device
Predicate Device(s): Luxsano AB OmniLight Fluorescent Pulsed Light System, K032191 Palomar Medical Technologies, Inc. StarLux Pulsed Light System, K041086
Device Description
The Candela Fluorescent Pulsed Light System is designed for selective photothermolysis in aesthetic treatments. The technology is based on a unique combination of patented fluorescent filter technology, selected spectrums of light source emission; pulse forming and sapphire based skin cooling system. It operates through creation of a directed incoherent light beam of spectrally balanced light. The light is spectrally filtered to remove the shorter wavelength portions (UV) most likely to cause harm to the skin. A sapphire crystal light guide is used to transport the resultant longer wavelength light to a laser-dye impregnated polymer filter sheet, which absorbs the part of the lamp light spectrum below it's emission and emits the selected wavelength band (417- 1200 nm) to 615 - 1200 nm, and non fluorescent 650 nm - 1200 nm and 850 - 1200 nm.
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A liquid-to-air cooling system, including a fluid pump, fluid reservoir, deionization filter, interlocks and forced convection liquid-to-air heat exchanger and a water to water ThermoElectrical cooler is used to maintain the hand piece components at the proper temperature. The electronic components of the system include multiple safety features to protect both the user and patient, and the pulsed-light system itself.
A microprocessor based system controller is used to monitor and direct all system functions. Users of the Candela Fluorescent Pulsed Light System select parameters such as desired energy density (fluence) level and filter wavelength and monitor operation via electronic controls and a display panel. The control panel is also used to enable or disable the triggering of the Candela Fluorescent Pulsed Light System, and to obtain feedback from the system, such as the number of pulses delivered or spot size selected. The Candela Fluorescent Pulsed Light System supports 40mm x 20mm, 20mm x 20mm, 10mm x 20mm, 7mm x 15mm, 7mm x 7mm.
Description of Intended Use
The Candela Fluorescent Pulsed Light System is indicated for treatment in the following uses:
Hair removal in all skin types according to the Fitzpatrick scale. Permanent Hair Reduction Treatment of Vascular Lesions
Treatment of Inflammatory Acne (acne vulgaris)
Treatment of Benign Pigmented Epidermal and Cutaneous Lesions including warts, scars and striae.
Rationale for Substantial Equivalence
The Candela Fluorescent Pulsed Light System, has the same intended use and utilizes similar functional features (including power output, spot size, repetition rate, energy, and fluence) and matches key design aspects (including wavelength, light generation medium, power supply, cooling and controls system) as the currently legally marketed predicate devices.
The Candela Fluorescent Pulsed Light System shares similar methods of operation, and intended uses, and therefore is substantially equivalent to the currently legally marketed OmniLight Fluorescent Pulsed Light System K032191 held by Luxsano AB and the StarLux Pulsed Light System K041086 held by Palomar Medical Technologies predicate devices.
Safety and Effectiveness Information
The Candela Fluorescent Pulsed Light System is substantial equivalent to the currently legally marketed Luxsano AB OmniLight Fluorescent Pulsed Light System, K032191 and the Palomar Medical Technologies, Inc. StarLux Pulsed Light System, K041086 predicate devices in intended use and technological features and therefore the risks and benefits are comparable to the predicate devices.
We therefore believe that there are no new questions of safety or effectiveness raised by the introduction of the Candela Fluorescent Pulsed Light System.
Conclusion
Base on the similarities in indications for use, design features, and functional features the Candela Fluorescent Pulsed Light System has been shown to be substantially equivalent to the current legally marketed predicate devices.
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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 eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circle around the eagle. The logo is black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Candela Corporation % Mr. Jeffrey Roberts Manager, Regulatory Affairs 530 Boston Post Road Wayland, Massachusetts 01778
FEB 5 2007
Re: K063800
Trade/Device Name: Candela Fluorescent Pulsed Light 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: December 21, 2006 Received: December 22, 2006
Dear Mr. Roberts:
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 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.
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Page 2 - Mr. Jeffrey Roberts
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. Melkerson
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): K063072_ K 06380
Device Name: Candela Fluorescent Pulsed Light System
Indications for Use:
The Candela Fluorescent Pulsed Light System is indicated for the following uses:
Hair removal in all skin types to the Fitzpatrick scale. Permanent Hair Reduction.
Treatment of Vascular Lesions
Treatment of Inflammatory Acne (acne vulgaris)
Treatment of Benign Pigmented Epidermal and Cutaneous Lesions including warts, scars and striae.
| Prescription Use | X | AND/OR | Over-The-Counter Use | |
|---|---|---|---|---|
| (Part 21 CFR 801 Subpart D) | (21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices Page 1 of 1
| 510(k) Number | 103810 |
|---|---|
| --------------- | -------- |
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§ 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.