(90 days)
Not Found
No
The device description focuses on the physical components and laser parameters, with no mention of AI or ML capabilities. The software mention refers to general computer-controlled medical device guidance, not AI/ML specific guidance.
Yes
The device is described as a "surgical instrument" and its intended use is to "treat leg veins," which are therapeutic actions.
No
The Ceralas H Laser System is described as a "surgical instrument" that treats leg veins by delivering laser radiation. There is no mention of it being used for diagnosis, only for therapeutic procedures.
No
The device description clearly outlines hardware components including a console, footswitch, handpiece, and a diode laser module, indicating it is a physical medical device with integrated software, not a software-only device.
Based on the provided information, the Ceralas H Laser System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "treat leg veins in dermatology and plastic surgery procedures." This describes a therapeutic procedure performed directly on the patient's body.
- Device Description: The device description details a surgical laser system that delivers light pulses to the patient's skin. This is a physical intervention, not a diagnostic test performed on a sample taken from the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting markers, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The Ceralas H Laser System is a therapeutic device used for treatment.
N/A
Intended Use / Indications for Use
The Ceralas H Laser System is a surgical instrument indicated to treat leg veins in dermatology and plastic surgery procedures. Specific indications for the Ceralas H Laser System include the treatment of leg veins.
The Ceralas H 808nm Diode Laser System is indicated to treat leg veins in dermatology and plastic surgery procedures.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The Ceralas H Laser System is a complete, self-contained compact surgical laser that utilizes gallium alumnum arsenide (GaAlAs) semiconductor diodes to generate near-infrared laser radiation. The laser system consists of a console, footswitch, and handpiece which are connected to the device's console. The diode laser is enclosed in a rugged, factory aligned, environmentally protective module. The handpiece is placed against the patient's skin and a pulse of light is delivered to the skin surface when the footswitch and handpiece trigger are depressed.
The wavelength for the Ceralas H Laser System is 808 ± 20nm. The laser delivers pulsed light with a selectable pulse duration of 5-30 millsseconds and a fluence of 10-40J/cm2. The corresponding pulse energy delivered through the 9x9mm handpiece is 8-32 Joules. The laser pulses are generated at a maximum pulse repetition frequency of up to 1 Hz. Additionally, the software and software development activities are in accordance with FDA's guidance document. "Reviewer Guidance For Computer Controlled Medical Devices Undergoing 510(k) Review."
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
leg veins
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dermatology and plastic 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)
None required.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
K 983950
FEB 3 1339
510(k) Summary Ceralas Diode Laser System
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
CeramOptec, Inc. 515 Shaker Road East Longmeadow, Massachusetts 01028 (413) 525-0600 Phone: Facsimile: (413) 525-0611
Carol J. Morello, V.M.D. Contact Person: February 4, 1998 Date prepared:
Name of Device and Name/Address of Sponsor
Ceralas H 808nm Diode Laser System CeramOptec, Inc. 515 Shaker Road East Longmeadow, Massachusetts 01028
Classification Name
Laser, Surgical Diode Laser System
Predicate Device
Star Medical Technologies, Inc.'s StarLight™ Pulsed Diode Array Laser System (K974346 and K973324).
Intended Use
The Ceralas H Laser System is a surgical instrument indicated to treat leg veins in dermatology and plastic surgery procedures. Specific indications for the Ceralas H Laser System include the treatment of leg veins. As explained below, the Ceralas H Laser System is substantially equivalent to Star Medical Technologies, Inc.'s StarLight™ Pulsed Diode Array Laser System (K974346 and K973324).
1
Technological Characteristics and Substantial Equivalence
The Ceralas H Laser System is a complete, self-contained compact surgical laser that utilizes gallium alumnum arsenide (GaAlAs) semiconductor diodes to generate near-infrared laser radiation. The laser system consists of a console, footswitch, and handpiece which are connected to the device's console. The diode laser is enclosed in a rugged, factory aligned, environmentally protective module. The handpiece is placed against the patient's skin and a pulse of light is delivered to the skin surface when the footswitch and handpiece trigger are depressed.
The wavelength for the Ceralas H Laser System is 808 ± 20nm. The laser delivers pulsed light with a selectable pulse duration of 5-30 millsseconds and a fluence of 10-40J/cm2. The corresponding pulse energy delivered through the 9x9mm handpiece is 8-32 Joules. The laser pulses are generated at a maximum pulse repetition frequency of up to 1 Hz. Additionally, the software and software development activities are in accordance with FDA's guidance document. "Reviewer Guidance For Computer Controlled Medical Devices Undergoing 510(k) Review."
The Ceralas H Laser System and the StarLight Diode Laser System have equivalent technological characteristics. For instance, both devices are diode lasers which operate at a similar beam mode, fluence, reperition rate, pulse width, and pulse energy. The principle technological distinction between the two devices is that the StarLight Diode Laser System's wavelength is 800nm and the Ceralas H Laser System's wavelength is 808+20nm. However, it is not believed that the difference between the devices' wavelength raises any new questions of safety and effectiveness. In summary, although there are minimal differences between the Ceralas H Laser System and its predicate device, these differences are minor and raise no new questions of safety and efficacy.
Performance Data
None required.
2
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 the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, represented by three curved lines. The logo is black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
3 1039 FEB
Mr. Jonathan S. Kahan c/o Hogan & Hartson, L.L.P. 555 13th Street, NW Washington, D.C. 20004-1109
Re: K983950 Trade Name: Ceralas Diode Laser System (Model H) Regulatory Class: II Product Code: GEX Dated: November 4, 1998 Received: November 5, 1998
Dear Mr. Kahan:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action, In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2 -- Mr. Jonathan Kahan
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Hyst Aurelius
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page_of
x983950 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Ceralas H 808nm Diode Laser System
Indications For Use:
The Ceralas H 808nm Diode Laser System is indicated to treat leg veins in dermatology and plastic surgery procedures.
Hok Diodes
(Division Sign-Off) Division of General Restorative Devices x983950 510(k) Number .
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH. Office of Device Evaluation (ODE)
(Optional Format 3-10-98)
X Prescription Use . Prescription Sul.109)
(Per 21 CFR 801.109)