(69 days)
Not Found
No
The device description focuses on the hardware components and laser technology, with no mention of AI or ML capabilities.
Yes
The device is described as being used for various medical applications such as dermatology, surgical applications, and oral/periodontal surgery, which are all therapeutic in nature. The applications listed "ablation, vaporization, excision, incision and coagulation of soft tissue" clearly indicate treatment rather than diagnostic purposes.
No
Explanation: The Velure Family of Diode Lasers are described as being used for "ablation, vaporization, excision, incision and coagulation of soft tissue," and various surgical applications. These are all therapeutic and treatment-oriented uses, not diagnostic ones. There is no mention of the device being used to identify or analyze a medical condition.
No
The device description clearly states it consists of a self-contained console, fiber delivery system, handpiece, footswitch, safety goggles, and warning labels, all of which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Velure Family of Diode Lasers are used to directly interact with and treat human tissue through ablation, vaporization, excision, incision, and coagulation. They are used for surgical and aesthetic procedures.
- Intended Use: The intended uses listed (dermatology, hair removal, oral, periodontal, surgical applications) all involve direct treatment of the patient's body, not analysis of samples taken from the body.
- Device Description: The description details a laser system with a fiber delivery system and handpieces, designed for delivering energy to tissue. There is no mention of analyzing biological samples.
Therefore, the Velure Family of Diode Lasers falls under the category of therapeutic or surgical devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Velure Family of Diode Lasers are intended for use in dermatology, hair removal, oral, periodontal and surgical applications that require ablation, vaporization, excision, incision and coagulation of soft tissue.
Velure S5 532nm (Green) Diode Laser
Applications:
Vascular Lesions
Pigmented Lesions
Velure S8/15, Velure S8/30 and Velure S800 808nm Diode Laser
Applications:
Vascular Lesions
Unwanted Hair Removal
Velure S9/15, Velure S9/30 980mm Diode Laser
Applications: Surgical Cut and coagulate General Surgery GYN ENT Neuro Urgology
Velure S9/7D and Velure S9/15D 980nm Diode Laser
Applications: Oral and Periodontal Surgery
Bleaching (tooth whitening)
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The Velure Family of Diode Lasers emit a beam of coherent light in either continuous wave or pulse mode at the following wavelengths.
523nm - Velure S5
808nm - Velure S8/15, Velure S8/30 and Velure S800
980nm - Velure S9/7D, Velure S9/15, Velure S9/15D and Velure S9/30
Each laser consists of a self-contained console, an SMA fiber delivery system with handpiece, a footswitch, safety goggles and warning label set. The main console contains a Diode laser, a 635nm pilot laser, micro-controller, air cooling system and power supply. The console has an on-off key switch and emergency stop push button. The SMA fiber delivery system connects the console to a variety of fiber optic handpieces and scanner (Velure S5 only). Refer to the enclosed brochures and instruction manuals for complete published information.
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)
Performance Data: None provided
Clinical Data: None provided
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
Image /page/0/Picture/0 description: The image shows a handwritten string of characters. The string begins with the letter 'K', followed by the numbers '063396'. The characters are written in a cursive style, with varying stroke thicknesses. The image appears to be a close-up of the handwritten string.
JAN 1 7 2007
510(k) Summary of Safety and Effectiveness for the Velure Family of Diode Lasers and Delivery Device Accessories
1. General Information
| Submitter: | Lasering S.r.l
Via Staffette Partigiane, 54
Modena, 4110 Italy |
| ------------ | ---------------------------------------------------------------------- |
|---|
Contact Person: Allen R. Howes TTI Medical 2246 Camino Ramon San Ramon, CA 94583 925-355-0750 (F) 925-355-0777
Preparation Date: November 6, 2006
2. Device Name:
Trade/Proprietary Name: Velure Family of Diode Lasers and Delivery Device Accessories Common/Usual Name: General Surgical Laser System Classification Name: Laser Instrument, Surgical Powered Product Code: GEX Panel: 79
3. Predicate Devices:
The Velure Family of Diode Lasers and deliver device accessories are substantially equivalent to the predicate devices Adept Ultralite 532 (K042496) and the Intermedic Diode Laser Family (K053540.
4. Device Description:
The Velure Family of Diode Lasers emit a beam of coherent light in either continuous wave or pulse mode at the following wavelengths.
523nm - Velure S5
808nm - Velure S8/15, Velure S8/30 and Velure S800
980nm - Velure S9/7D, Velure S9/15, Velure S9/15D and Velure S9/30
1
Each laser consists of a self-contained console, an SMA fiber delivery system with handpiece, a footswitch, safety goggles and warning label set. The main console contains a Diode laser, a 635nm pilot laser, micro-controller, air cooling system and power supply. The console has an on-off key switch and emergency stop push button. The SMA fiber delivery system connects the console to a variety of fiber optic handpieces and scanner (Velure S5 only). Refer to the enclosed brochures and instruction manuals for complete published information.
5. Intended Use:
The Velure Family of Diode Lasers are intended for use in dermatology, hair removal, oral, periodontal and surgical applications that require ablation, vaporization, excision, incision and coagulation of soft tissue.
Velure S5
532nm (Green) Diode Laser
Applications:
Vascular Lesions
Pigmented Lesions
Velure S8/15, Velure S8/30 and Velure S800 808nm Diode Laser
Applications:
Vascular Lesions
Unwanted Hair Removal
2
Velure S9/15 and Velure S9/30
980nm Diode Laser Applications: Surgical Cut and coagulate General Surgery GYN ENT Neuro Urology
Velure S9/7D and Velure S9/15D 980nm Diode Laser Applications: Oral and Periodontal Surgery
Bleaching (tooth whitening)
Specifications - Refer to pages 5 and 6 in the Instruction Manuals for published specifications
Performance Data: None provided 6.
- Clinical Data: None provided
8. Conclusion:
The Velure Family of Diode Lasers and delivery device accessories are substantially equivalent to predicate diode laser systems in commercial distribution for use in Dermatology, Aesthetic Surgery, Plastic Surgery, General Surgery, Dentistry, ENT, Neurosurgery and Gynecology.
j
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three bars representing its wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Lasering S.r.l. % Mr. Allen R. Howes TTI Medical 2246 Camino Ramon San Ramon, California 94583
JAN 17 2007
Re: K063396
Trade/Device Name: Velure Family of Diode Lasers and Delivery Device Accessories Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: GEX Dated: November 6, 2006 Received: November 9, 2006
Dear Mr. Howes:
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 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.
4
Page 2 - Mr. Allen R. Howes
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 Office of Compliance at (240) 276-0210 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/industry/support/index.html.
Sincerely yours,
Qof
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Number K063396
Device Name: Velure Family of Diode Lasers and Delivery Device Accessories.
Indications For Use:
The Velure Family of Diode Lasers are intended for use in dermatology, hair removal, oral, periodontal and surgical applications that require ablation, vaporization, excision, incision and coagulation of soft tissue.
Velure S5 532nm (Green) Diode Laser
Applications:
Vascular Lesions
Pigmented Lesions
Prescription Use
(part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) SIZIL= Division Page 1 of 4 Division of General, Restorative, and Neurological Devices 510 (k) Number.
6
510(k) Number K063396
Device Name: Velure Family of Diode Lasers and Delivery Device Accessories.
Indications For Use: Continued from previous page
Velure S8/15, Velure S8/30 and Velure S800 808nm Diode Laser
Applications: Vascular Lesions
Unwanted Hair Removal
Prescription Use (part21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C)
:
(PLEASE DO NOT WRITE ABOVE THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Page 2 of 4
ત્ત્વ-સ
7
510(k) Number K 063396
Device Name: Velure Family of Diode Lasers and Delivery Device Accessories.
Indications For Use: Continued from previous page
Velure S9/15, Velure S9/30 980mm Diode Laser
Applications: Surgical Cut and coagulate General Surgery GYN ENT Neuro Urgology
Prescription Use (part21 CFR 801 Subpart D)
AND/OR Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE ABOVE THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Page 3 of 4
.
8
510(k) Number K 063396
Device Name: Velure Family of Diode Lasers and Delivery Device Accessories.
Indications For Use: Continued from previous page
Velure S9/7D and Velure S9/15D 980nm Diode Laser
Applications: Oral and Periodontal Surgery
Bleaching (tooth whitening)
Prescription Use (part21 CFR 801 Subpart D)
AND/OR Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE ABOVE THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Page 4 of 4