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510(k) Data Aggregation
K Number
K243014Device Name
EyeQ nanoECP
Manufacturer
EyeQ Inc.
Date Cleared
2025-06-18
(264 days)
Product Code
HQF
Regulation Number
886.4390Why did this record match?
Product Code :
HQF
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EyeQ nanoECP System is indicated for intraoperative photocoagulation of the ciliary processes in the treatment of glaucoma, and for evaluation of the internal ocular structures in patients with dense opacifications of the anterior segment which do not allow a posterior view.
Glaucoma - This instrument is indicated for the treatment of glaucoma in patients who have failed with conventional topical and systemic medications, or previous laser photocoagulation, or trabeculectomy and other filtering procedures, or cyclocryotherapy or other cyclodestructive procedures.
Device Description
Not Found
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K Number
K240615Device Name
Leos Laser and Endoscopy System
Manufacturer
Beaver-Visitec International, Inc.
Date Cleared
2025-04-03
(394 days)
Product Code
HQF
Regulation Number
886.4390Why did this record match?
Product Code :
HQF
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Leos system is indicated for intraoperative photocoagulation of the ciliary processes in the treatment of glaucoma, proliferative retinopathies, retinal detachment, and for evaluation of the internal ocular structures in patients with dense opacifications of the anterior segment which do not allow a posterior view.
**Glaucoma** - This instrument is indicated for the treatment of glaucoma in patients who have failed with conventional topical and systemic medications, or previous laser photocoagulation, or trabeculectomy and other filtering procedures, or cyclocryotherapy or other cyclodestructive procedures.
**Vitreoretinal Surgery** - The endoscopically controlled endophotocoagulation that is possible with the ophthalmic laser endoscope is also useful for endophotocoagulation:
- During vitreous surgery to produce chorioretinal scar around retinal breaks or retinotomy sites.
- To perform intraoperative panretinal photocoagulation (PRP) in proliferative retinopathies.
- To perform intraoperative retinal photocoagulation on a scleral buckle.
- To perform intraoperative photocoagulation around focal neovascularization
Device Description
The Leos Laser and Endoscopic System is a next generation ophthalmic laser and endoscopy system used for the treatment of glaucoma, vitreoretinal diseases, and intraocular visualization. The system contains an 810 nm powered diode laser delivered by the stainless-steel endoscopic laser probe (trade name: VueProbe), which is placed into eye tissue to illuminate and visualize the target tissue and deliver laser energy under direct visualization. The console is a fully integrated portable device, containing a laser module assembly, viewing and control monitors, and a wireless footswitch for activating the laser. The larger passive monitor is for viewing the endoscopic video image and key treatment information, while the smaller touchscreen is used for parameters selection, rotation and viewing. The camera chip uses CMOS technology and is located at the tip of the probe. The LED light source is located within the plastic handpiece of the probe and illumination fibers carry the light to the tip. Additionally, the probe contains a laser fiber within its full length.
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K Number
K242397Device Name
LYNX Photocoagulator
Manufacturer
Norlase Aps
Date Cleared
2024-10-25
(73 days)
Product Code
HQF
Regulation Number
886.4390Why did this record match?
Product Code :
HQF
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Norlase LYNX Photocoagulator is intended to be used in ophthalmic laser procedures including retinal and macular photocoagulation, iridotomy, and trabeculoplasty.
Device Description
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K Number
K233911Device Name
VISULAS combi
Manufacturer
Carl Zeiss Meditec AG
Date Cleared
2024-09-06
(269 days)
Product Code
HQF
Regulation Number
886.4390Why did this record match?
Product Code :
HQF
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
VISULAS combi is intended for use in photocoagulating and photodisrupting ocular tissues in the treatment of diseases of the eye, including:
• Photocoagulation of the retina
- Trabeculoplasty
- · Iridotomy
- · Posterior capsulotomy
· Posterior membranectomy
This device is Prescription Use (Rx) only.
Device Description
VISULAS combi is an ophthalmic laser used for standard photocoagulation treatments of ocular tissue with 532 nm wavelength and standard photodisruption treatments of ocular tissues at a wavelength of 1064 mm. VISULAS combi is operated in the following treatment modes:
- single-spot mode (software license VERTE) -
- multi-spot mode (software license VITE)
- YAG disruption mode (software license YAG). -
VISULAS combi consists of a laser console, touch control panel, optional laser light applicators such as laser slit lamp or laser indirect ophthalmoscope, foot switch and instrument table. The device can also be used with various accessories, such as SL Imaging Solution, contact lenses or Applanation Tonometer.
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K Number
K232417Device Name
MR Q; MR Q SUPINE; MR Q SLT
Manufacturer
Meridian AG
Date Cleared
2024-01-25
(167 days)
Product Code
HQF
Regulation Number
886.4390Why did this record match?
Product Code :
HQF
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MR Q and the MR SUPINE are intended to perform:
- Posterior capsulotomy -
- Iridotomy -
The MR Q SLT in YAG mode is intended to perform:
- Posterior capsulotomy -
- -Iridotomy
The MR Q SLT in SLT mode is intended to perform:
- Selective laser trabeculoplasty
Device Description
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K Number
K230722Device Name
Eagle device
Manufacturer
BELKIN Vision Ltd.
Date Cleared
2023-12-08
(267 days)
Product Code
HQF, HOF
Regulation Number
886.4390Why did this record match?
Product Code :
HQF
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Eagle device is indicated for use in selective laser trabeculoplasty (SLT).
Device Description
The Eagle device is a Q-switched, 532 nm-wavelength, frequency-doubled Nd:YAG laser that is intended for use in performing selective laser trabeculoplasty. The laser spots produced by the Eagle device have a 400 um spot size, a 3 ns pulse duration, and a 50-Hz pulse repetition rate. The sequence of laser spots consists of 120 spots in a predefined circumferential elliptical pattern delivered at a pre-defined pulse energy level. The spots are delivered through the limbus to the trabecular meshwork in a non-contact fashion, without the need for the use of a contact gonioscopy lens. The device automatically locates the treatment location. The treatment location may be adjusted slightly by the operator. Once confirmed by the operator, the device then automatically applies the laser treatment sequence to the limbal region of the eye, while the eye tracker compensates for any eye movement. The default energy setting is 1.8 mJ/pulse.
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K Number
K232051Device Name
VISULAS green
Manufacturer
Carl Zeiss Meditec
Date Cleared
2023-10-24
(106 days)
Product Code
HQF
Regulation Number
886.4390Why did this record match?
Product Code :
HQF
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
VISULAS green is intended for use in photocoagulating ocular tissues of the treatment of diseases of the eve, including
- · Photocoagulation of the retina
- Trabeculoplasty
- · Iridotomy
Device Description
VISULAS green is an ophthalmic laser used for standard photocoagulation treatments of ocular tissue with 532 nm wavelength. VISULAS green is operated in single-spot mode or in multi-spot mode.
VISULAS green consists of a laser console, touch control panel, optional laser light applicators such as laser slit lamp or laser indirect ophthalmoscope, foot switch and instrument table. The device can also be used with various accessories, such as SL Imaging Solution, contact lenses or Applanation Tonometer.
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K Number
K230350Device Name
VISULAS yag
Manufacturer
Carl Zeiss Meditec Inc
Date Cleared
2023-09-22
(225 days)
Product Code
HQF
Regulation Number
886.4390Why did this record match?
Product Code :
HQF
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
VISULAS yag is intended for use in photodisrupting ocular tissue in the treatment of diseases of the eye, including Posterior capsulotomy, Iridotomy and Posterior Membranectomy.
This device is for Prescription Use (Rx) only.
Device Description
VISULAS yag uses a Q-switched, flashlamp-pumped solid-state laser for photodisruption treatments of diseases of the eye, including posterior capsulotomy, iridotomy and membranectomy. Laser radiation is generated by means of a neodymium-doped yttrium aluminum garnet (Nd:YAG) gain medium inside the laser source. The emitted laser radiation with a near-infrared wavelength of = 1064 nm has a pulse duration of < 4 ns (full-width half-maximum; FWHM) and a focal diameter of 6.5 um ± 20%. The maximum energy output per pulse is 9 to 13 mJ in single-burst mode.
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K Number
K231011Device Name
Merilas 532 shortpulse, Merilas 577 shortpulse, Merilas 810 shortpulse
Manufacturer
Meridian AG
Date Cleared
2023-09-12
(155 days)
Product Code
HQF, HOF
Regulation Number
886.4390Why did this record match?
Product Code :
HQF
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MERILAS 810 shortpulse laser is indicated for:
- Photocoagulation
- Iridotomy
- Trabeculoplasty
- Thermotherapy
The MERILAS 532 shortpulse laser is indicated for:
- Photocoagulation
- Iridotomv
- Trabeculoplasty
The MERILAS 577 shortpulse laser is indicated for:
- Photocoagulation
- Iridotomy
- Trabeculoplasty
Device Description
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K Number
K230228Device Name
Iridex 532 Laser; Iridex 577 Laser; Iridex Laser (532 nm and 577 nm models)
Manufacturer
Iridex Corporation
Date Cleared
2023-02-23
(27 days)
Product Code
HQF, GEX
Regulation Number
886.4390Why did this record match?
Product Code :
HQF
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Iridex® Laser Console (532 model) are solid state lasers that are used to deliver laser energy in either continuous wave pulse (CW-pulse® mode, for ophthalmic applications (532 and 577 models) and for Ear, Nose, and Throat (Otolaryngology) applications (532 model only).
Iridex® 532 Laser
The Iridex® 532 Laser is indicated for use in soft and fibrous tissue, including osseous tissue incision, excision, coagulation, vaporization, ablation and vessel hemostasis in the medical specialties of, ear, nose and throat (ENT)/otolaryngology, and ophthalmology as follows:
Ophthalmology
Indicated for retinal photocoagulation, laser trabeculoplasty, iridoplasty including:
- · Retinal photocoagulation (RPC) for the treatment of
- o Diabetic retinopathy, including:
- Nonproliferative retinopathy
- Macular edema
- Proliferative retinopathy
- o Retinal tears and detachments
- o Lattice degeneration
- o Age-related macular degeneration (AMD)
- o Retinopathy of prematurity
- o Sub-retinal (choroidal) neovascularization
- o Central and branch retinal vein occlusion
- · Laser trabeculoplasty, iridotomy, iridoplasty for the treatment of glaucoma, including
- o Primary open angle/Closed angle
Ear, Nose, and Throat (ENT)/Otolaryngology
Otosclerotic Hearing loss and/or diseases of the inner ear:
- · Stapedectomy
- · Stapedotomy
- · Myringotomies
- · Lysis of Adhesions
- · Control of Bleeding
- · Removal of Acoustic Neuromas
- · Soft tissue Adhesion in Micro/Macro Otologic Procedures
Iridex® 577 Laser
The Iridex® 577 Laser is indicated for use in soft and fibrous tissue, including osseous tissue incision, excision, coagulation, vaporization, ablation and vessel hemostasis in the medical specialty of ophthalmology as follows:
Ophthalmology
Indicated for use in photocoagulation of both anterior and posterior segments including:
- · Retinal photocoagulation, panretinal photocoagulation and intravitreal endophotocoagulation of vascular and structural abnormalities of the retina and choroid including: o Proliferative and nonproliferative diabetic retinopathy o Choroidal neovascularization o Branch retinal vein occlusion o Age-related macular degeneration (AMD) o Retinal tears and detachments o Retinopathy of prematurity · Iridotomy, iridectomy and trabeculoplasty in angle closure glaucoma and open angle glaucoma
Device Description
The Iridex 532/577 Laser consoles are solid state lasers that are used to deliver laser energy in continuous wave and MicroPulse® for ophthalmic applications and (for 532 only) ear, nose, and throat (ENT) / otolaryngology applications. The Iridex® 532 Laser delivers a 532 nm wavelength (green) laser emission, and the Iridex® 577 Laser delivers a 577mm wavelength (true-yellow) laser emission.
The Iridex 532 Laser and the Iridex 577 Laser systems are comprised of a laser console with footswitch and an optical fiber delivery device. Each laser console model contains two laser diodes as follows:
- Iridex 532 Laser: 532 nm for Treatment and 650 nm for Aiming beam ●
- Iridex 577 Laser: 577 nm for Treatment and 650 nm for Aiming beam ●
imaging optics, power supply, control electronics, and software/embedded firmware (with microprocessor). Lasing can only be initiated from the footswitch.
Optical fiber Delivery Devices are provided separately.
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