(69 days)
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)
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).
The provided document is a 510(k) summary for a medical device called the "Velure Family of Diode Lasers and Delivery Device Accessories." This type of submission to the FDA is typically used to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific performance acceptance criteria through a clinical study with detailed statistical outcomes.
Based on the content of the document, here's an analysis of the requested information:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria or specific performance data from a clinical trial that would typically be used to demonstrate the device meets such criteria. Instead, it relies on demonstrating substantial equivalence to predicate devices. The "Performance Data" section explicitly states: "None provided."
2. Sample size used for the test set and the data provenance
No test set sample size is mentioned because no clinical performance study demonstrating acceptance criteria was conducted or provided in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no ground truth establishment for a test set is described.
4. Adjudication method for the test set
Not applicable, as no test set requiring adjudication is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a laser system, not an AI-assisted diagnostic or imaging device used by readers. No MRMC study was conducted or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a laser system, not an algorithm.
7. The type of ground truth used
Not applicable, as no ground truth for a clinical study is described. The "ground truth" for this 510(k) summary is based on the performance and safety profiles of the predicate devices.
8. The sample size for the training set
Not applicable, as no training set for an algorithm is described.
9. How the ground truth for the training set was established
Not applicable, as no training set for an algorithm is described.
Summary of the Document's Approach to Acceptance:
The "Velure Family of Diode Lasers and Delivery Device Accessories" received a 510(k) clearance by demonstrating substantial equivalence to existing legally marketed predicate devices, specifically the Adept Ultralite 532 (K042496) and the Intermedic Diode Laser Family (K053540).
The key "proof" of acceptance in this context is the FDA's letter stating: "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..."
The document explicitly states:
- "Performance Data: None provided" (page 2)
- "Clinical Data: None provided" (page 2)
Therefore, the acceptance of this device for marketing in the US was based on a comparison of its design, materials, intended use, and technological characteristics to existing predicate devices, rather than on new clinical studies showing specific performance metrics against pre-defined acceptance criteria. The assumption is that if it's substantially equivalent to already approved devices, it is equally safe and effective.
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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.lVia Staffette Partigiane, 54Modena, 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
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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
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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
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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.
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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
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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.
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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
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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
.
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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
§ 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.