(245 days)
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No
The description focuses solely on the laser technology and its physical effects on tissue, with no mention of AI, ML, image processing, or data-driven algorithms.
Yes
The device is described as an "Ophthalmic Er:YAG Laser System" that "causes rapid vaporization, or ablation, in both hard and soft biological tissues," which is indicative of a therapeutic function for treating ophthalmic soft tissue. Additionally, its predicate devices are also therapeutic laser systems.
No
Explanation: The device description indicates that the VisioLite® Ophthalmic Er:YAG Laser System is used for rapid vaporization or ablation of tissues, which is a therapeutic function, not a diagnostic one. Its intended use is for ophthalmic soft tissue surrounding the eye and orbit, also suggesting treatment rather than diagnosis.
No
The device description explicitly states it is a "Laser System" and describes the creation of a laser beam, indicating it is a hardware device that uses laser technology for tissue ablation.
Based on the provided information, the VisioLite® is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens (like blood, urine, or tissue samples) taken from the human body to provide information about a person's health. This testing is done outside the body (in vitro).
- VisioLite® Function: The VisioLite® is a laser system that directly interacts with and ablates tissue on the body (in vivo). It's a surgical or therapeutic device, not a diagnostic one that analyzes samples.
- Intended Use: The intended use clearly states it's for treating "ophthalmic soft tissue surrounding the eye and orbit," which is a direct application to the patient's body.
Therefore, the VisioLite® falls under the category of a therapeutic or surgical device, not an IVD.
N/A
Intended Use / Indications for Use
The VisioLite® is indicated for the ophthalmic soft tissue surrounding the eye and orbit.
Product codes
GEX
Device Description
The VisioLite® Ophthalmic Er: Y AG Laser System creates a laser beam with a wavelength of 2940nm, which is highly absorbed by water, collagen and hydroxy apatite and therefore causes rapid vaporization, or ablation, in both hard and soft biological tissues. Because the absorption is highly efficient, tissue removal is very precise with virtually no collateral thermal damage.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
soft tissue surrounding the eye and orbit
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 the logo for ACE VISION. The logo consists of an eye-like shape with a six-pointed star in the center. Below the eye is the text "ACEVISION" in a bold, sans-serif font. The logo is simple and modern, and the use of the eye shape suggests that the company is involved in vision care or a related field.
OCT 3 ี 2007
510(k) Summary (per 21 CFR 807.92)
Applicant I. ACE VISION GROUP 247 N. Westmonte Road Altamonte Springs, FL 32714
Tim Elliott, VP Operations Contact Person: Tel: (216) 632-1988 Fax: (440) 815-2262 Email: telliott@acevisiongroup.com
Date Prepared: August 17, 2007
II. Device Name
Proprietary Name: | VisioLite® Ophthalmic Er:YAG Laser System |
---|---|
Common/ Usual Name: | Laser instrument, surgical, powered |
Classification Name: | Laser surgical instrument for use in general and |
plastic surgery and in dermatology | |
Regulation Number: | 878.4810 |
Product Codes: | GEX |
Classification: | 2 |
Classification Panel: | General & Plastic Surgery |
III. Predicate Device
The VisioLite® Ophthalmic Er: YAG Laser System is substantially equivalent to the Oculase MD from Biolase Technology Inc and the Laserscope Vela Erbium: YAG laser system. The Oculase MD was cleared by the FDA under 510(k) K052354 and the Vela Erbium:YAG laser system was cleared by the FDA under 510(k) K971843
IV. Intended Use of the Device
The VisioLite® is indicated for the ophthalmic soft tissue surrounding the eye and orbit.
V. Description of the Device
The VisioLite® Ophthalmic Er: Y AG Laser System creates a laser beam with a wavelength of 2940nm, which is highly absorbed by water, collagen and hydroxy apatite and therefore causes rapid vaporization, or ablation, in both hard and soft biological tissues. Because the absorption is highly efficient, tissue removal is very precise with virtually no collateral thermal damage.
1
Image /page/1/Picture/0 description: The image shows the logo for ACE VISION. The logo consists of an eye-shaped symbol with a six-pointed star in the center. Below the symbol is the text "ACE VISION" in a bold, sans-serif font. Underneath "ACE VISION" are the words "REAL COMPANY. REAL PEOPLE."
The VisioLite® Ophthalmic Er:YAG Laser System is equivalent in design to the Delight laser System from Hoya ConBio.
VI. Summary of the Technical Characteristics
Type of Laser | Er:YAG |
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Laser Beam Wavelength | 2940 nm (invisible, mid-infrared) |
Energy Output | Up to 350 mJ |
Type of Operation | Pulsed Only, Pulse Width |