FREQUENCY DOUBLED ND:YAG PHOTOCOAGULATOR(VIRIDIS) FREQUENCY DOUBLED ND:YAG PHOTOCOAGULATOR(EVERGREEN 532)
K960867 · B.V. Intl. S.A. · GEX · May 14, 1996 · General, Plastic Surgery
Device Facts
| Record ID | K960867 |
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| Device Name | FREQUENCY DOUBLED ND:YAG PHOTOCOAGULATOR(VIRIDIS) FREQUENCY DOUBLED ND:YAG PHOTOCOAGULATOR(EVERGREEN 532) |
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| Applicant | B.V. Intl. S.A. |
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| Product Code | GEX · General, Plastic Surgery |
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| Decision Date | May 14, 1996 |
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| Decision | SESE |
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| Submission Type | Traditional |
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| Regulation | 21 CFR 878.4810 |
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| Device Class | Class 2 |
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| Attributes | Therapeutic |
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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 Story
The VIRIDIS (also marketed as EVERGREEN 532) is an ophthalmic laser photocoagulator. It utilizes an Nd:YAG slab laser source pumped by an 810 nm laser diode, with a KTP crystal for frequency doubling to produce a 532 nm treatment beam. A 670 nm red laser diode serves as the aiming beam. The device delivers energy through three interchangeable systems: slit lamp adaptor, indirect ophthalmoscope adaptor, or endocular probe adaptor. It is operated by ophthalmologists in clinical settings to perform retinal photocoagulation. The device provides selectable exposure durations (0.01 to 3.0 seconds) and a maximum output power of 1.5 Watts. By delivering precise laser energy to the retina, the device enables the treatment of conditions such as proliferative diabetic retinopathy, macular degeneration, and retinal detachment, aiming to stabilize or improve patient vision.
Clinical Evidence
No clinical data provided; bench testing only.
Technological Characteristics
Laser source: Nd:YAG slab; Pumping: 810 nm laser diode; Frequency doubling: KTP crystal; Output wavelength: 532 nm; Aiming beam: 670 nm diode laser; Delivery systems: Slit lamp, indirect ophthalmoscope, endocular probe; Cooling: Solid state; Power: Max 1.5 W; Pulse repetition rate: 12,000 Hz; Focal spot size: 50 micrometers; Exposure range: 0.01 to 3.0 seconds.
Indications for Use
Indicated for patients requiring retinal photocoagulation for ophthalmic conditions including Proliferative Diabetic Retinopathy, Macular Degeneration, and Retinal Detachment.
Regulatory Classification
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.
Predicate Devices
- EMERALD from Crystal Focus
- NOVUS 2000 from Coherent
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Submission Summary (Full Text)
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BVI BIOVISION
K960867 MAY 14 1996 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 :
Jean Abascal
B. V. International
89, Boulevard Etienne CLEMENTEL
63100 Clermont-Ferrand
FRANCE
Contact person : Jean Abascal
Telephone number : (33) 73 25 62 27
FAX number : (33) 73 25 54 11
**Date Prepared :** February 21st 1996
**Device Name :**
Classification Name : Ophthalmic Laser
Common / Usual Name : Ophthalmic Laser Photocoagulator
Proprietary Name : VIRIDIS
Frequency Doubled Nd:YAG Photocoagulator
Other Proprietary Name : EVERGREEN 532
Frequency Doubled Nd:YAG Photocoagulator
**Classification :**
Devices Classification Panel : Ophthalmic
Product code : 86HQF
Ophthalmic lasers are Class II medical devices in accordance with 21 CFR § 886.4390.
**Note :** "VIRIDIS" and "EVERGREEN 532" are identical.
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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BVI BIOVISION
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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 following :
- 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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BVI BIOVISION
510(k) Summary of Safety and Effectiveness
## Device Comparison
| Manufacturer | Coherent Medical | B.V.International | Crystal Focus |
| --- | --- | --- | --- |
| Model | NOVUS 2000 | VIRIDIS or EVERGREEN 532 | EMERALD |
| Same Intended Use | Retinal Photocoagulation for the treatment of Ophthalmic conditions. | | |
| Same type of Delivery systems | 1°) Slit Lamp adaptor with Zoom
2°) Indirect Ophthalmoscope adaptor
3°) Endocular Probe | | |
| Lasing medium | Argon | ND:YAG | ND:YAG |
| Pumping system | High Voltage | Diode Laser 810 nm | Flash |
| Doubling Frequency Crystal | --- | KTP | KTP |
| Output Wavelength | 488 - 514 nm | 532 nm | 532 nm |
| Pulsing system | Continuous | Pseudo-Continuous | Pulsed |
| Pulse Duration | --- | 25 micro sec. | 1 micro sec. |
| Average Power | 2.5 W | 1.5 W | 2 W |
| Pulse Repetition Rate | Continuous | 12 000 Hz | 10 000 Hz |
| Mini. Focal Spot Size : Diameter | 50 micro meters | 50 micro meters | 50 micro meters |
| Aiming beam : | Coaxial with treatment beam | | |
| Aiming beam : type | He-Ne laser | Diode Laser | He-Ne laser |
| Aiming beam : Wavelength | 632 nm | 670 nm | 632 nm |
| Cooling method | Internally liquid cooled | Solid state cooling | Internally liquid cooled |
| Exposure Selections ( t ) | 0.01s to continuous | 0.01 -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 : Voltage | 208 - 240 Vac | 100 to 240 Vac | 208 - 240 Vac |
| Power requirements : Current | 45 A | 5 A | 13 A |
