(53 days)
The device is intended for use with an appropriate laser for vein ablation procedures.
The ELAtionTM Endovenous Laser Procedure Kit is indicated for the treatment of varicose veins and varicosities associated with superficial reflux of the greater saphenous vein and for treatment of incompetence and reflux of superficial veins in the lower extremity. The kit is intended to be used with an 810 nm, 940 nm, or 980 nm laser.
Not Found
I cannot answer your request the text that you provided is a 510k summary, not a study.
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Kogory
| GeneralProvisions | Submitter Name:Address:Telephone Number:Fax Number:Contact Person:Date of Preparation:Registration Number: | Merit Medical Systems, Inc. (Merit)1600 West Merit ParkwaySouth Jordan, UT 84095MAR - 6 2009(801) 208-4748(801) 253-6960Susan ScottJanuary 8, 20091721504 |
|---|---|---|
| SubjectDevice | Trade Name:Common/Usual Name:Classification Name: | ELAtionTM Endovenous Laser Procedure KitVein Ablation Procedure Kit78 GEX - Laser Instrument, Surgical, Powered |
| PredicateDevices | Trade Name:Common/Usual Name:Classification Name:Premarket Notification: | AngioDynamics, Inc. NeverTouchTM 600 µm Fiberand VenaCure® Procedure KitGreater Saphenous Vein Procedure kit78 GEX - Laser Instrument, Surgical PoweredK070378, concurrence date Mar 09, 2007 |
| Trade Name:Common/Usual Name:Classification Name:Premarket Notification: | Vari-Lase® Endovenous Laser Procedure KitLaser Instrument Fiber and Procedure Kit78 GEX - Laser Surgical Instrument for use inGeneral and Plastic Surgery and in DermatologyK051287, concurrence date Jul. 29, 2005 | |
| Classification | Class II21 CFR §878.4810General & Plastic Surgery | |
| PerformanceStandards | No performance standards have been established by FDA under section 514of the Federal Food, Drug and Cosmetic Act. | |
| Intended Use | The device is intended for use with an appropriate laser for vein ablationprocedures. | |
| Indicationsfor Use | The ELAtionTM Endovenous Laser Procedure Kit is indicated for the treatmentof varicose veins and varicosities associated with superficial reflux of thegreater saphenous vein and for treatment of incompetence and reflux ofsuperficial veins in the lower extremity. The kit is intended to be used with an810 nm, 940 nm, or 980 nm laser. |
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510(k) Summary
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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 stylized image of an eagle with its wings spread, and its head turned to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 3 2009
Merit Medical Systems, Inc. % Ms. Susan Scott 1600 West Merit Parkway South Jordan, Utah 84095
Re: K090084
Trade/Device Name: ELAtion™ Endovenous Laser Procedure Kit 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: February 27, 2009 Received: March 2, 2009
Dear Ms. Scott:
This letter corrects our substantially equivalent letter of March 6, 2009.
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. Isting 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
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Page 2 - Ms. Susan Scott
forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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.
Sincerely yours,
Mark M Millman
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 Statement
510(k) Number (if known):
Device Name:
ELAtion™ Endovenous Laser Procedure Kit
Indications for Use:
The ELAtion™ Endovenous Laser Procedure Kit is indicated for the treatment of varicose veins and varicosities associated with superficial reflux of the greater saphenous vein and for treatment of incompetence and reflux of superficial veins in the lower extremity. The kit is intended to be used with an 810 nm, 940 nm, or 980 nm laser.
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)
Neil RP Oyler for msm
(Division Sign-O Division of General, Restorative, and Neurological Devices
510(k) Number K09008
Page 1 of
§ 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.