(189 days)
Not Found
No
The summary describes a laser system for soft tissue surgery and does not mention any AI or ML capabilities.
Yes
Explanation: The device is intended for surgical procedures such as incision, excision, vaporization, ablation, hemostasis, or coagulation of soft tissue, which are all therapeutic interventions.
No
The device is described as a laser system for surgical procedures like incision, excision, vaporization, ablation, hemostasis, or coagulation of soft tissue. These are therapeutic actions, not diagnostic ones.
No
The device is described as a laser system intended for surgical procedures, indicating it is a hardware device that delivers laser light. The description of its intended use and the predicate devices (other laser systems) further support this conclusion. There is no mention of software being the primary or sole component.
No, 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 of the body (in vitro).
- Ceralas D 810 Function: The Ceralas D 810 is a laser system intended for surgical procedures performed on the body (in vivo). It delivers laser light directly to soft tissue for incision, excision, vaporization, ablation, hemostasis, or coagulation.
The intended use and device description clearly indicate that this is a surgical device used for direct treatment of tissue within the body, not for analyzing samples taken from the body.
N/A
Intended Use / Indications for Use
The Ceralas D 810 is intended for delivery of laser light to soft tissue in the contact or non-contact mode during surgical procedures, including via endoscopes, introducers, or catheters. The Ceralas D 810 is generally indicated for incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), dental procedures, arthroscopy, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology, neurosurgery (peripheral nervous system), pulmonary surgery, and cardiothoracic surgery. This Ceralas D 810 is specifically indicated for hemostasis or coagulation of soft tissue (including cardiac tissue).
Product codes
OCL, GEX
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue in ear, nose and throat and oral surgery (otolaryngology), dental procedures, arthroscopy, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology, neurosurgery (peripheral nervous system), pulmonary surgery, and cardiothoracic surgery. This Ceralas D 810 is specifically indicated for hemostasis or coagulation of soft tissue (including cardiac tissue).
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)
The device complies with the following voluntary consensus standards: 21 C.F.R. 11te device complics with and Addinest; IEC 601-1; IEC 601-2-22; and EN 60825-1.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Ceralas D 810 Diode Laser System, Ceralas D 980 Diode Laser System, CardioFocus, Inc.'s Diode Laser System used with CardioFocus, Inc.'s Surgical Lightstic
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
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
MAR 1 9 2004
510(k) Summary Ceralas D 810 Diode Laser System × × 328 × 4
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
biolitec. Inc. 515 Shaker Road East Longmeadow, Massachusetts 01028 (413) 525-0600 Phone: Facsimile: (413) 525-0611
Carol J. Morello, V.M.D. Contact Person: March 18, 2004 Date prepared:
Name of Device and Name/Address of Sponsor
Ceralas D 810 Diode Laser System biolitec. Inc. 515 Shaker Road East Longmeadow, Massachusetts 01028
Classification Name
Surgical laser
Predicate Devices
Ceralas D 810 Diode Laser System Ceralas D 980 Diode Laser System CardioFocus, Inc.'s Diode Laser System used with CardioFocus, Inc.'s Surgical Lightstic
Intended Use/Indication for Use
The Ceralas D 810 is intended for delivery of laser light to soft tissue in the contact or non-contact mode during surgical procedures, including via endoscopes, introducers, or catheters. The Ceralas D 810 is generally indicated for incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), dental procedures, arthroscopy, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology, neurosurgery (peripheral nervous system), pulmonary surgery, and
1
cardiothoracic surgery. This Ceralas D 810 is specifically indicated for hemostasis cartion of soft tissue (including cardiac tissue).
Performance Data
The device complies with the following voluntary consensus standards: 21 C.F.R. 11te device complics with and Addinest; IEC 601-1; IEC 601-2-22; and EN 60825-1.
Substantial Equivalence
The Ceralas D 810 has the same intended use and the exact same technological The Ocrains I 810 with the exceptiously cleared Ceralas D 810 with the exception of a characterismes to the phe handpiece for hemostasis or coagulation of cardiac tissue. In addition, all of the Ceralas D 810's general and specific indications for use are In additions of at least one of its predicate devices. The Ceralas D 810 also has very similar technological characteristics as its predicate devices. Thus, the Ceralas D 810 is substantially equivalent.
2
FEB 2 1 2008
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Biolitec. Inc. c/o Mr. Jonathan S. Kahan Hogan & Hartson, L.L.P. 555 Thirteenth Street, NW Washington, DC 20004
Re: K032864
Trade/Device Name: Cardiac Ceralas D 810 Diode Laser 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 (two) Product Code: OCL, GEX Dated: December 22, 2003 Received: December 22, 2003
Dear Mr. Kahan:
This letter corrects our substantially equivalent letter of March 19, 2004.
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 (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 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.
3
Page 2 - Mr. Jonathan Kahan
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.
This letter will allow you to continue 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) 276-0120. 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/dsma/dsmamain.html
Sincerely yours,
el.mall.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known):_K 032864
Device Name: Ceralas D 810 Diode Laser System
The Ceralas D 810 is intended for delivery of laser light to soft tissue in the contact or non-contact mode during surgical procedures, including via endoscopes, introducers, or catheters. The Ceralas D 810 is generally indicated for incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), dental procedures, arthroscopy, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology, neurosurgery (peripheral nervous system), pulmonary surgery, and cardiothoracic surgery. This Ceralas D 810 is specifically indicated for hemostasis or coagulation of soft tissue (including cardiac tissue).
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | X (Per 21 C.F.R. 801.109) |
|---|---|
| ------------------ | --------------------------- |
OR
| Over-The-Counter Use | _ (Optional Format 1-2-96) |
|---|---|
| ---------------------- | ---------------------------- |
Miriam C. Provost
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
| 510(k) Number | K632864 |
|---|---|
| --------------- | --------- |
510(k) Number.