(90 days)
Diomed 810nm Surgical Laser, Ceralas D10-60 810nm Diode Laser, Ceralas D 980 nm Diode Laser
Not Found
No
The summary describes a diode laser device for treating varicose veins and makes no mention of AI or ML capabilities.
Yes
The device is indicated for the "treatment of varicose veins and varicosities associated with superficial reflux of the greater saphenous vein," which clearly defines a therapeutic purpose.
No
The device is indicated for the treatment of varicose veins and varicosities, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly states it is a "Diode Laser" and includes an "ELVeS kit," indicating it is a hardware device with physical components for treatment.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the treatment of varicose veins and varicosities. IVDs are used for the diagnosis of diseases or conditions.
- Device Description: The device is a laser used for surgical treatment. IVDs are typically reagents, instruments, or systems used to examine specimens from the human body (like blood, urine, or tissue) to provide information for diagnosis.
- No mention of analyzing biological samples: The description focuses on the laser's function and its use in accessing and treating the vein directly. There is no mention of analyzing any biological samples.
Therefore, this device falls under the category of a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
In addition to the already cleared indications: For use in treatment of varicose veins and varicosities associated with superficial reflux of the greater saphenous vein.
Product codes
GEX
Device Description
The Ceralas D810 Diode Laser and the predicate devices operate with a power range of 1-60W in the CW or pulsed mode. The Ceralas D180 contains an ELVeS kit for gaining access to the vasculature to treat varicose veins and varicosities associated with superficial reflux of the greater saphenous vein.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
greater saphenous vein
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Diomed 810nm Surgical Laser, Ceralas D10-60 810nm Diode Laser, Ceralas D 980 nm Diode Laser
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
30700
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JUN = 4 2003
510(k) Summary Ceralas Diode Laser System
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Biolitec, Inc. 515 Shaker Road East Longmeadow, Massachusetts 01028 Phone: (413) 525-0600 Facsimile: (413) 525-0611
Contact Person: Carol J. Morello, V.M.D. Date prepared: March 4, 2003
Name of Device and Name/Address of Sponsor
Ceralas Diode Laser System (Model D10-60) 810nm Biolitec, Inc. 515 Shaker Road East Longmeadow, MA 01028
Classification Name
Surgical laser
Predicate Device
Diomed 810nm Surgical Laser Biolitec Ceralas D10-60 810nm Diode Laser Biolitec Ceralas D 980 nm Diode Laser
Intended Use / Indications For Use
In addition to the already cleared indications: For use in treatment of varicose veins and varicosities associated with superficial reflux of the greater saphenous vein.
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Technological Characteristics
The Ceralas D810 Diode Laser and the predicate devices operate with a power range of 1-60W in the CW or pulsed mode. The Ceralas D180 contains an ELVeS kit for gaining access to the vasculature to treat varicose veins and varicosities associated with superficial reflux of the greater saphenous vein.
Substantial Equivalence
The Ceralas D810 with ELVeS has the exact same intended use and indications for use as its predicate devices, the cleared Diomed 810 laser, the Ceralas D810, and the Ceralas D980. The Ceralas D810's proposed varicose vein indication, which is a modification to its cleared superficial vein reflux indication, is exactly the same as the Diomed 810's varicose vein indication. The laser component of the Ceralas D810 with ELVeS kit is identical to the cleared Ceralas D810 laser, and its ELVeS kit is identical to the Ceralas D 980's cleared ELVeS kit. Moreover, each component of the Ceralas D810's and Ceralas D980's ELVeS kit is a cleared device, a preamendment device, or a 510(k) exempt device for the same general intended use. Any minor technical differences between the Ceralas D980 and the Ceralas D810 do not raise the question of safety or effectiveness. Thus, the Ceralas D810's cleared with ELVeS kit is substantially equivalent to a combination of its predicate devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains an abstract image of an eagle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top half of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
്വUN - 4 2003
Biolitec, Inc. c/o Mr. Jonathan S. Kahan Hogan & Hartson, L.L.P. 555 Thirteenth Street, NW Washington, D.C. 20004
Re: K030700 Trade/Device Name: Ceralas D10-60 810 nm Diode Laser System with Endo Laser Vein System 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: March 4, 2003 Received: March 6, 2003
Dear Dr. Morello:
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 (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.
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Page 2 - Mr. Jonathan S. Kahan
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 (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Sincerely yours,
Mark N Mellema
Celia M. Witten, Ph.D., M.D. 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):__K 6 30 760
Device Name: Ceralas D10-60 810 nm Diode Laser System with Endo Laser Vein System Kit
Indicated for use in treatment of varicose veins and varicosities associated with superficial reflux of the greater saphenous vein.
(PLEASE DO NOT WRITE BELOW THIS LINE … CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use J (Per 21 C.F.R. 801.109)
OR
Over-The-Counter Use_ (Optional Format 1-2-96)
Mark N Mulkerson
Division Sign Off
Division of General, Restorative and Neurological Devices
510(k) Number K030700