(91 days)
The MedLite™ C1 Q-Switched Nd:YAG Laser is intended for: Treatment of Pigmented Lesions Incision, Excision, Ablation, Vaporization of Soft Tissue for General Dermatology
Not Found
The provided text does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria. The document is a 510(k) summary for the MedLite™ C1 Q-Switched Nd:YAG Laser, which focuses on demonstrating substantial equivalence to a predicate device rather than providing performance data against specific acceptance criteria.
The "Nonclinical Performance Data" and "Clinical Performance Data" sections both state "None," indicating that no specific performance studies were included in this submission to prove device performance against acceptance criteria.
Therefore, I cannot extract the requested information from the provided text.
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JUN 17 2005
KA50696, p. 1 of 1
9. 510(k) Summary
| Company: | HOYA ConBio (formerly Continuum Electro-Optics, Inc.)47733 Fremont BlvdFremont, CA 94538(800) 532-1064 phone(510) 445-4550 fax |
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| Contact: | Jim GreenVice President of Engineering |
| Device Trade Name: | MedLite™ C1 Q-Switched Nd:YAG Laser |
| Common Name: | Medical Laser System |
| Classification Name: | Instrument, surgical, powered, laser |
| Classification Code: | 79-GEX |
| Equivalent Device(s): | MedLite™ C3 Q-Switched Nd:YAG Laser |
| Intended Use: | The MedLite™ C1 Q-Switched Nd:YAG Laser is intended for:Treatment of Pigmented Lesions Incision, Excision, Ablation, Vaporization of Soft Tissue for General Dermatology |
| Comparison: | The MedLite™ C1 Q-Switched Nd:YAG Laser maintains the samefundamental technology and intended uses (at 532 nm) as itslegally marketed predicate device, the MedLite™ C3 Q-SwitchedNd:YAG Laser. |
| Nonclinical PerformanceData: | None |
| Clinical Performance Data: | None |
| Additional Information: | None |
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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem consisting of three abstract human figures or profiles facing to the right, with flowing lines suggesting movement or connection.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 17 2005
Mr. Jim Green Vice President of Engineering Hoya Photonics Incorporated 47733 Fremont Boulevard Fremont, California 94538
Re: K050696
Trade/Device Name: MedLite™ C' Q-Switched Nd: YAG Laser 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: March 16, 2005 Received: March 21, 2005
Dear Mr. Green:
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. Jim Green
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin maneting your arrantial equivalence of your device to a legally premarket notification. "The I DTC Intamged basification 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 If you desire specific acvice ior your acc (240) 276-0115 . Also, please note the regulation entitled, Comact the Office of Comphalled at (21 the Part 807.97). You may obtain Misolanding by release to premainter to premainter the Act from the Division of Small other general information on your response Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
R. A. M.
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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6. Indications for Use Statement
510(k) Number:
Device Name:
MedLite™ C' Q-Switched Nd:YAG Laser
Indications for Use:
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Treatment of pigmented lesions .
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Incision, excision, ablation, vaporization of soft tissue . for general dermatology
Prescription Use __ X (21 CFR 801 Subpart D)
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)
ﻟﻜﻦ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍ .. 1000 Division of General, Restorative and Neurelogical Devices
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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.