(79 days)
No
The device description focuses on the hardware components and basic software control for laser parameters, with no mention of AI/ML algorithms for image analysis, treatment planning, or other functions.
Yes
The device is intended for clinical treatment (incision, excision, ablation, vaporization and coagulation of soft tissue, specifically treatment of vascular lesions) using laser energy.
No
The device description indicates its purpose is for Incision, excision, ablation, vaporization, and coagulation of soft tissue, which are therapeutic actions, not diagnostic ones.
No
The device description clearly outlines hardware components such as a laser source, fiber optic beam delivery, hand piece, footswitch, and a physical control panel (LCD and touch-screen display). While software is mentioned for calculating treatment fluence, it is integral to the operation of the physical laser system, not a standalone software device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "Incision, excision, ablation, vaporization and coagulation of soft tissue" and "Treatment of vascular lesions." These are all procedures performed on the patient's body, not on samples taken from the patient's body.
- Device Description: The description details a laser system used for direct treatment of tissue. There is no mention of analyzing biological samples (blood, urine, tissue biopsies, etc.).
- Lack of IVD Characteristics: An IVD device is designed to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis.
Therefore, the V-Raser is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The V-Raser is intended for Incision, excision, ablation, vaporization and coagulation of soft tissue.
Specific Indications: Treatment of vascular lesions.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The V-RASER Diode System is a modified Diodent Micro 980. It will use similar specifications (laser medium, excitation method, fiber optic beam delivery, electrical requirements, physical specifications) as the Diodent Micro 980. The laser source of this device is a solid-state Gallium Aluminum Arsenide (GaAlAs) semiconductor diode. It produces invisible laser energy at the 980-nanometer wavelength. The delivery system consists of removable flexible HCS (hard clad silica) optical treatment fiber assembly connected to a lightweight, hand piece that has two different size end pieces (tips) to adjust the laser beam to specific spot sizes. Activation occurs when the operator enables the laser by a key switch, enters the Ready Mode and presses the footswitch. Releasing the footswitch suspends laser treatment. A color LCD and touch-screen display panel allows the operator to adjust or set the laser output level. The laser operates in a pulsed mode and will have a removable stainless steel end piece for establishing the proper focal length for the treatment. The hand piece will be manually attached (i.e., screwed on) to a connector to the fiber assembly. The spot size will be selected on the control panel and the software will calculate the treatment fluence accordingly.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft 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)
Nonclinical Performance Data: None
Clinical Performance Data: None
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.
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
pg 1 of 2
510(k) Summary or 510(k) Statement 5.
V-RASER Diode Laser System 510k Summary
Image /page/0/Picture/4 description: The image shows the logo for HOYA ConBio. The text "HOYA" is in large, bold, black letters, followed by "ConBio" in a smaller, thinner font. There is a horizontal line underneath the text. The logo appears to be for a company or organization named HOYA ConBio.
47733 Fremont Boulevard, Fremont, California 945 510-445-4500 www.conbio.com 510-445-4550 Fax
| Submitter: | HOYA ConBio, Inc.
47733 Fremont Blvd.
Fremont, California 94538
Phone: 510-445-4500
Fax: 510-445-4550 |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Mr. Jim Green
Vice President of Engineering |
| Date Summary Prepared: | November 21, 2007 |
| Device Trade Name: | V-RASER Diode Laser System |
| Common Name: | Dermatology Laser System |
| Classification Name: | Instrument, surgical, powered, laser
79-GEX |
| Classification Code: | 878.4810 Laser surgical instrument for use in general and
plastic surgery and in dermatology (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. |
| Equivalent Device: | Diodent Micro 980 (K063384), Iridex Varilite (K041930), |
| Device Description: | The V-RASER Diode System is a modified Diodent Micro
980. It will use similar specifications (laser medium,
excitation method, fiber optic beam delivery, electrical
requirements, physical specifications) as the Diodent Micro
980. The laser source of this device is a solid-state Gallium
Aluminum Arsenide (GaAlAs) semiconductor diode. It
produces invisible laser energy at the 980-nanometer
wavelength. The delivery system consists of removable
flexible HCS (hard clad silica) optical treatment fiber |
1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1
1
K0733332
| | assembly connected to a lightweight, hand piece that has
two different size end pieces (tips) to adjust the laser beam
to specific spot sizes. Activation occurs when the operator
enables the laser by a key switch, enters the Ready Mode
and presses the footswitch. Releasing the footswitch
suspends laser treatment. A color LCD and touch-screen
display panel allows the operator to adjust or set the laser
output level. The laser operates in a pulsed mode and will
have a removable stainless steel end piece for establishing
the proper focal length for the treatment. The hand piece
will be manually attached (i.e., screwed on) to a connector
to the fiber assembly. The spot size will be selected on the
control panel and the software will calculate the treatment
fluence accordingly. |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use: | Incision, excision, ablation, vaporization and coagulation of
soft tissue. Indicated for the treatment of vascular lesions. |
| Comparison: | The V-RASER Diode Laser System is comparable to its
predicate and parent device in terms of its indications for
use, technical specifications, operating performance
features, and general design features. |
| Nonclinical Performance
Data: | None |
| Clinical Performance
Data: | None |
| Additional Information: | None requested at this time. |
2
Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or other bird-like figure, composed of three curved lines.
FEB 1 4 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
HOYA ConBio, Inc. % Liza Burns and Associates Ms. Liza Burns Regulatory/Clinical Consultant 19722 Westview Drive Twain Harte, California 95383
Re: K073332
Trade/Device Name: V-RASER 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 Product Code: GEX Dated: November 21, 2007 Received: November 21, 2007
Dear Ms. Burns:
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
3
Page 2 - Ms. Liza Burns
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 yours.
Mark N. Mulkerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K073332 pg 1 of 1
Indications for Use
510(k) Number (if known):
V-RASER Diode Laser System Device Name:
Intended Use:The V-Raser is intended for Incision, excision, ablation, vaporization and coagulation of soft tissue.
Specific Indications: Treatment of vascular lesions.
Prescription Use Over-The-Counter Use × AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Philip Van Off
Page __ of ___________________________________________________________________________________________________________________________________________________________________
(Division Sign-Off Division of General, Restorative, and Neurological Devices
510(k) Number L013352
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