K Number
K960867
Device Name
FREQUENCY DOUBLED ND:YAG PHOTOCOAGULATOR(VIRIDIS) FREQUENCY DOUBLED ND:YAG PHOTOCOAGULATOR(EVERGREEN 532)
Manufacturer
Date Cleared
1996-05-14

(71 days)

Product Code
Regulation Number
878.4810
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Used with a slit lamp adaptor, this system is indicated for use in retinal photocoagulation for the treatment of ophthalmic conditions including : Proliferative Diabetic Retinopathy, Macular Degeneration, and Retinal Detachment.
Device Description
The laser source is an Nd: YAG Slab, pumped by a Laser Diode (810 nm), with a frequency doubling crystal (KTP). The treatment beam is delivered through a delivery system and is aimed using a Red Laser Diode (670 nm). The 3 possible delivery systems are the followirig : - Slit lamp adaptor - Indirect ophthalmoscope adaptor - Endocular probe adaptor Output power of all these delivery systems have a maximum of 1.5 Watts.
More Information

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No
The summary describes a laser photocoagulation system with different delivery methods. There is no mention of AI, ML, image processing, or any data-driven decision-making components.

Yes
The device is used for "retinal photocoagulation for the treatment of ophthalmic conditions" such as "Proliferative Diabetic Retinopathy, Macular Degeneration, and Retinal Detachment," which are medical treatments.

No
The device is used for treatment (retinal photocoagulation) and does not mention any diagnostic capabilities.

No

The device description clearly outlines hardware components such as a laser source (Nd: YAG Slab, Laser Diode, KTP crystal), a treatment beam delivery system, and aiming laser (Red Laser Diode), along with various physical adaptors (slit lamp, indirect ophthalmoscope, endocular probe). This indicates it is a hardware-based medical device, not software-only.

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
  • Device Function: The provided description clearly states the device is a laser system used for retinal photocoagulation. This is a therapeutic procedure performed directly on the patient's eye to treat ophthalmic conditions. It does not involve testing samples taken from the body.

The device is a therapeutic laser system, not a diagnostic device that analyzes biological samples.

N/A

Intended Use / Indications for Use

Used with a slit lamp adaptor, this system is indicated for use in retinal photocoagulation for the treatment of ophthalmic conditions including : Proliferative Diabetic Retinopathy, Macular Degeneration, and Retinal Detachment.

Product codes (comma separated list FDA assigned to the subject device)

86HOF

Device Description

The laser source is an Nd: YAG Slab, pumped by a Laser Diode (810 nm), with a frequency doubling crystal (KTP).

The treatment beam is delivered through a delivery system and is aimed using a Red Laser Diode (670 nm).

The 3 possible delivery systems are the followirig :

  • Slit lamp adaptor

  • Indirect ophthalmoscope adaptor

  • Endocular probe adaptor

Output power of all these delivery systems have a maximum of 1.5 Watts.

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

Retinal

Indicated Patient Age Range

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Intended User / Care Setting

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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)

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

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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.

Not Found

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.

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Image /page/0/Picture/0 description: The image shows the logo for BIOVISION. The logo consists of the letters "BVI" in large, bold, black font, stacked on top of four horizontal black lines. Below the lines, the word "BIOVISION" is written in a smaller, bold, black font.

K960867 Page 1 / 3

510(k) Summary of Safety and Effectiveness

The following information is submitted in accordance with the requirements of 21 CFR 807.92 :

Submitted by :

Zhatta

Jean Abascal B. V. International 89, Boulevard Etienne CLEMENTEL 63100 Clermont-Ferrand FRANCE

Contact person :

Jean Abascal

(33) 73 25 62 27

(33) 73 25 54 11

Telephone number : FAX number :

Date Prepared :

February 21st_1996

Device Name :

Classification Name : Ophthalmic Laser

Common / Usual Name : Ophthalmic Laser Photocoagulator

VIRIDIS Proprietary Name : Frequency Doubled Nd:YAG Photocoagulator

Other Proprietary Name : EVERGREEN 532 Frequency Doubled Nd:YAG Photocoagulator

Classification :

Devices Classification Panel : Ophthalmic Product code : 86HOF Ophthalmic lasers are Class II medical devices in accordance with 21 CFR § 886.4390.

"VIRIDIS" and "EVERGREEN 532" are identical. Note : Only the housing is different.

B.V.INTERNATIONAL : 89, Boulevard Etienne Clémentel - 63100 Clermont-Ferrand -Tel : 73 25 62 27 FRANCE Fax : 73 25 54 11

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Image /page/1/Picture/1 description: The image shows the logo for BIOVISION. The logo consists of the letters "BVI" in large, bold, black font, stacked on top of four horizontal black lines. Below the lines, the word "BIOVISION" is written in a smaller, black font with rounded letterforms.

510(k) Summary of Safety and Effectiveness

Predicate Devices :

  • An other Frequency Doubled Nd:YAG Photocoagulator :

The EMERALD from Crystal Focus

  • A Continuous-wave Argon Laser .:

The NOVUS 2000 from Coherent

Device Description

The laser source is an Nd: YAG Slab, pumped by a Laser Diode (810 nm), with a frequency doubling crystal (KTP).

The treatment beam is delivered through a delivery system and is aimed using a Red Laser Diode (670 nm).

The 3 possible delivery systems are the followirig :

  • Slit lamp adaptor

  • Indirect ophthalmoscope adaptor

  • Endocular probe adaptor

Output power of all these delivery systems have a maximum of 1.5 Watts.

Intended Use :

Used with a slit lamp adaptor, this system is indicated for use in retinal photocoagulation for the treatment of ophthalmic conditions including : Proliferative Diabetic Retinopathy, Macular Degeneration, and Retinal Detachment.

Predicate Comparison :

A chart comparing the VIRIDIS (or EVERGREEN 532) with the 2 predicate devices, demonstrating substantial equivalence, is attached.

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Image /page/2/Picture/0 description: The image shows a logo for "BVI BIOVISION". The logo is in black and white. The letters "BVI" are in large, bold font, with three horizontal lines underneath. Below the lines, the word "BIOVISION" is written in a smaller, but still bold, font.

510(k) Summary of Safety and Effectiveness

Device Comparison

ManufacturerCoherent MedicalB.V.InternationalCrystal Focus
ModelNOVUS 2000VIRIDIS
or
EVERGREEN 532EMERALD
Same Intended UseRetinal Photocoagulation for the treatment of Ophthalmic
conditions.
Same type of
Delivery systems1°) Slit Lamp adaptor with Zoom
2°) Indirect Ophthalmoscope adaptor
3°) Endocular Probe
Lasing mediumArgonND:YAGND:YAG
Pumping systemHigh VoltageDiode Laser
810 nmFlash
Doubling Frequency Crystal---KTPKTP
Output Wavelength488 - 514 nm532 nm532 nm
Pulsing systemContinuousPseudo-ContinuousPulsed
Pulse Duration---25 micro sec.1 micro sec.
Average Power2.5 W1.5 W2 W
Pulse Repetition RateContinuous12 000 Hz10 000 Hz
Mini. Focal Spot Size :
Diameter50 micro meters50 micro meters50 micro meters
Aiming beam :Coaxial with treatment beam
Aiming beam : typeHe-Ne laserDiode LaserHe-Ne laser
Aiming beam : Wavelength632 nm670 nm632 nm
Cooling methodInternally liquid
cooledSolid state coolingInternally liquid
cooled
Exposure Selections ( t )0.01s to
continuous0.01 -0.02 -0.05 -0.07 -
0.1 -0.2 -0.3 -0.4 -0.5
-0.7 -1.0 -2.0 -3.0 sec.0.01- 0.02- 0.05- 0.1-
0.2- 0.3- 0.4 -0.5 -0.7
-1.0 and 3.0 sec.
Power requirements : Voltage208 - 240 Vac100 to 240 Vac208 - 240 Vac
Power requirements : Current45 A5 A13 A