K Number
K070296
Device Name
VISIOLITE OPHTHALMIC ER: YAG LASER SYSTEM
Manufacturer
Date Cleared
2007-10-03

(245 days)

Product Code
Regulation Number
878.4810
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The VisioLite® is indicated for the ophthalmic soft tissue surrounding the eye and orbit.
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.
More Information

Not Found

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

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

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

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)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K052354, K971843

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)

K070296

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 LaserEr:YAG
Laser Beam Wavelength2940 nm (invisible, mid-infrared)
Energy OutputUp to 350 mJ
Type of OperationPulsed Only, Pulse Width