(120 days)
No
The summary describes a diode laser for surgical procedures and makes no mention of AI or ML.
Yes
The device is intended for the "treatment of reflux of the saphenous veins associated with varicose veins and varicosities," which indicates a therapeutic purpose.
No
The device is described as a diode laser intended for the "delivery of laser light to soft tissue" and "treatment of reflux of the saphenous veins." This indicates a therapeutic, rather than a diagnostic, function.
No
The device description explicitly states it is a diode laser, which is a hardware device, and mentions an ELVeS Kit, also a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body.
- Device Description and Intended Use: The Ceralas D1470 is a laser intended for delivering light directly to soft tissue in a non-contact mode during general surgery procedures. It is used to treat saphenous veins within the body.
- Lack of IVD Characteristics: The description does not mention any testing of samples, analysis of biological materials, or providing diagnostic information based on laboratory tests.
The device is a therapeutic laser used for a surgical procedure, not a diagnostic test performed on samples.
N/A
Intended Use / Indications for Use
The Ceralas D1470 is a diode laser that is intended for delivery of laser light to soft tissue in non-contact mode during general surgery procedures. The device is indicated for the treatment of reflux of the saphenous veins associated with varicose veins and varicosities.
Product codes
GEX
Device Description
The Ceralas D1470 is a diode laser. The Ceralas D1470 contains an ELVeS Kit for gaining access to the vasculature to treat varicose veins and varicosities associated with superficial reflux of the saphenous veins.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
saphenous veins
Indicated Patient Age Range
Not Found
Intended User / Care Setting
general surgery procedures
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)
Performance testing of the Ceralas D1470 demonstrates no significant difference as compared to the cleared CoolTouch CTEV Nd:YAG laser, the CoolTouch CT3S Nd:YAG laser, and the Sciton, Inc., Profile Multi-Platform System.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K040921, K051434, K061618, K062210, K060033
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
510(k) SUMMARY
Biolitec Inc.'s 15W Ceralas Diode 1470nm Laser System (Model D1470)
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Hogan & Hartson 555 13th Street NW Washington DC 20004
Phone: (202) 637-5794 Facsimile: (202) 637-5910
Contact Person: Jonathan S. Kahan
Date Prepared: December 5, 2007
Name of Device and Name/Address of Sponsor
15W Ceralas D 1470nm Diode Laser (Model D1470)
Biolitec, Inc. 515 Shaker Road East Longmeadow, MA 01028
Common or Usual Name
Diode Laser
Classification Name
Laser, Surgical Diode Laser System
Predicate Devices
CoolTouch Model CT3S Nd:YAG laser (K040921) CoolTouch CTEV and CT3S 1320 Nd:YAG laser (K051434) CoolTouch CTEV Nd:YAG Iaser (K061618) CoolTouch LC160 CTEV Nd:YAG laser (K062210) Sciton, Inc., Profile Multi-Platform System (K060033)
1
073063
Intended Use / Indications for Use
The Ceralas D1470 is a diode laser that is intended for delivery of laser light to soft tissue in non-contact mode during general surgery procedures. The device is indicated for the treatment of reflux of the saphenous veins associated with varicose veins and varicosities.
Technological Characteristics
The Ceralas D1470 has substantially similar technological characteristics as compared to the CoolTouch CTEV Nd:YAG laser, the CoolTouch CT3S Nd:YAG laser, and the Sciton, Inc., Profile Multi-Platform System. The Ceralas D1470 contains an ELVeS Kit for gaining access to the vasculature to treat varicose veins and varicosities associated with superficial reflux of the saphenous veins.
Performance Data
Performance testing of the Ceralas D1470 demonstrates no significant difference as compared to the cleared CoolTouch CTEV Nd:YAG laser, the CoolTouch CT3S Nd:YAG laser, and the Sciton, Inc., Profile Multi-Platform System.
Substantial Equivalence
The Ceralas D1470 is as safe and effective as the CoolTouch CTEV Nd:YAG laser, the CoolTouch CT3S Nd:YAG laser, and the Sciton, Inc., Profile Multi-Platform System. The Ceralas D1470 has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate devices. The minor technological differences between the Ceralas D1470 and its predicate device raises no new issues of safety or effectiveness. Thus, the Ceralas D1470 is substantially equivalent.
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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 features a stylized eagle with three stripes forming its body and wing. The eagle is positioned to the right of a circular text element that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA".
FEB 27 Your
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Biolitec, Inc. % Hogan & Hartson, L.L.P. Mr. Jonathan S. Kahan Columbia Square 555 Thirteenth Street, Northwest Washington, District of Columbia 20004
Re: K073063
Trade/Device Name: 15W Ceralas D 1470nm Diode Laser (Model D1470) 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 5, 2007 Received: December 5, 2007
Dear Mr. Kahan:
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
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Page 2 - Mr. Jonathan S. Kahan
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.
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) 276-0115. 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 the reporting 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 vours.
Mark N. Wilkerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known): K073063
Device Name: 15W Ceralas D 1470nm Diode Laser (Model D1470)
Indications for Use:
The Ceralas D1470 is a diode laser that is intended for delivery of laser light to soft tissue in non-contact mode during general surgery procedures. The device is indicated for the treatment of reflux of the saphenous veins associated with varicose veins and varicosities.
Prescription Use __ X__ (Part 21 C.F.R. 801 Subpart D) AND/OR
Over-The-Counter Use (21 C,F.R. 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page __ of ___________________________________________________________________________________________________________________________________________________________________
Mark A. Milliken
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K073063