(79 days)
Intended Use:The V-Raser is intended for Incision, excision, ablation, vaporization and coagulation of soft tissue.
Specific Indications: Treatment of vascular lesions.
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.
The provided 510(k) summary for the V-RASER Diode Laser System does not contain information about acceptance criteria or a study proving the device meets them.
Instead, it's a premarket notification for a medical device seeking substantial equivalence to a predicate device. The document explicitly states:
- Nonclinical Performance Data: None
- Clinical Performance Data: None
Therefore, I cannot provide the requested information. This device was cleared based on its similarity to existing, legally marketed devices, rather than through a study demonstrating its performance against specific acceptance criteria.
The information regarding the training set, test set, ground truth, expert qualifications, and adjudication methods is typically found in clinical or performance studies, which were not submitted for this 510(k) application.
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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 94538Phone: 510-445-4500Fax: 510-445-4550 |
|---|---|
| Contact: | Mr. Jim GreenVice 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, laser79-GEX |
| Classification Code: | 878.4810 Laser surgical instrument for use in general andplastic surgery and in dermatology (1) A carbon dioxidelaser for use in general surgery and in dermatology is alaser device intended to cut, destroy, or remove tissue bylight energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser deviceintended to destroy or coagulate tissue by light energyemitted by argon. |
| Equivalent Device: | Diodent Micro 980 (K063384), Iridex Varilite (K041930), |
| Device Description: | The V-RASER Diode System is a modified Diodent Micro980. It will use similar specifications (laser medium,excitation method, fiber optic beam delivery, electricalrequirements, physical specifications) as the Diodent Micro980. The laser source of this device is a solid-state GalliumAluminum Arsenide (GaAlAs) semiconductor diode. Itproduces invisible laser energy at the 980-nanometerwavelength. The delivery system consists of removableflexible 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
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K0733332
| assembly connected to a lightweight, hand piece that hastwo different size end pieces (tips) to adjust the laser beamto specific spot sizes. Activation occurs when the operatorenables the laser by a key switch, enters the Ready Modeand presses the footswitch. Releasing the footswitchsuspends laser treatment. A color LCD and touch-screendisplay panel allows the operator to adjust or set the laseroutput level. The laser operates in a pulsed mode and willhave a removable stainless steel end piece for establishingthe proper focal length for the treatment. The hand piecewill be manually attached (i.e., screwed on) to a connectorto the fiber assembly. The spot size will be selected on thecontrol panel and the software will calculate the treatmentfluence accordingly. | |
|---|---|
| Intended Use: | Incision, excision, ablation, vaporization and coagulation ofsoft tissue. Indicated for the treatment of vascular lesions. |
| Comparison: | The V-RASER Diode Laser System is comparable to itspredicate and parent device in terms of its indications foruse, technical specifications, operating performancefeatures, and general design features. |
| Nonclinical PerformanceData: | None |
| Clinical PerformanceData: | None |
| Additional Information: | None requested at this time. |
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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
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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
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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
12
§ 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.