(25 days)
The Ellex Integre is indicated for use in photocoagulation of both anterior and posterior segments of the eye including:
- Retinal photocoagulation and pan retinal photocoagulation of vascular and structural abnormalities of the retina and choroid including:
- proliferative and nonproliferative diabetic retinopathy;
- choroidal neovascularization;
- branch retinal vein occlusion;
- age-related macular degeneration;
- retinal tears and detachments:
- retinopathy of prematurity;
- Iridotomy, iridectorny, suturelysis and trabeculoplasty in angle closure glaucoma and open angle glaucoma
The Integre LP561 is an addition to the Ellex range of ophthalmic photocoagulators. The Integre family are designed for use by ophthalmologists in a clinic or outpatient facility, or in the Retinal Specialist's office. The Integre Duo LP1RG device is capable of producing focused pulses of red or green light with wavelengths of 670 nanometres (nm) and 532 nm respectively. The red and green beams may be used for the same treatments, but the red gives increased penetration of haemorrhaging tissue and fluids, and may also be used to treat ocular melanomas. The Integre LP561 is essentially the same device with a modification to the laser cavity optical components which results in a vellow (561 nm) treatment laser output. The reason for developing the new device is because the yellow wavelength is characterised by high absorption by melanin in the retinal pigment epithelium and choroids that reduces the penetration depth of the beam in the choroids, high absorption by haemoglobin that facilitates direct treatment for retinal/choroidal neovascularisation and no absorption in macular xanthophylls and higher transmission through cloudy media such as cataract or haze on the cornea. As with the Integre LP1RG, the laser pulses are accurately positioned on a structure within the patient's eye with the aid of a delivery device. The delivery device is an integrated slit-lamp microscope. An optional Laser Indirect Ophthalmoscope (LIO) can also be used.
This document describes a 510(k) premarket notification for a modified medical device, the Ellex Integre LP561 ophthalmic laser. The submission aims to demonstrate substantial equivalence to a predicate device, the Ellex Integre Duo LP1RG. As such, it focuses on comparing the modified device to the predicate device and other commercially available equivalents, rather than presenting a standalone study with defined acceptance criteria and performance results in the typical sense for a brand new device.
Therefore, the requested information, particularly regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria," does not directly apply in the context of this 510(k) submission. Instead, the "acceptance criteria" can be interpreted as demonstrating substantial equivalence to the predicate device, especially concerning safety and effectiveness. The "study" proving this is primarily the comparison tables and narrative provided within the 510(k) submission itself, highlighting technological similarities and equivalent intended use.
Here's an attempt to extract and frame the information according to your request, with caveats reflecting the nature of a 510(k) submission:
1. A table of acceptance criteria and the reported device performance
In a 510(k) for a modified device, the "acceptance criteria" are implicitly the characteristics and performance of the predicate device. The "reported device performance" is the characteristics and expected performance of the modified device, ideally showing it is at least as safe and effective as the predicate.
| Characteristic compared (as "Acceptance Criteria" implicit from Predicate) | Ellex Integre Duo LP1RG (Predicate Performance) | Integre LP561 (New Device Performance) |
|---|---|---|
| Intended Use | Photocoagulation of both anterior and posterior segments of the eye for conditions like diabetic retinopathy, choroidal neovascularization, retinal tears, glaucoma. | Substantially Equivalent (same intended use as the predicate, confirmed with minor rephrasing) |
| Laser Type | True CW Diode-Pumped Solid-State (DPSS) | True CW Diode-Pumped Solid-State (DPSS) |
| Laser Wavelength | 532 nm (green), 670 nm (red) | 561 nm (yellow) |
| Laser Power | 50-2000 mW (green), 50-1500 mW (red) | 50-1500 mW (yellow) |
| Exposure time settings (pulse duration) | 0.01 to 4.0 seconds adjustable in variable increments | 0.01 to 4.0 seconds adjustable in variable increments |
| Repeat mode Intervals | 0.1 to 1.0 seconds | 0.1 to 1.0 seconds |
| Laser Safety Class | 4/IV | 4/IV |
| Spot Size | 50 to 1000 µm | 50 to 1000 µm |
| Aiming Laser Type | Semi conductor laser diode | Semi conductor laser diode |
| Aiming Laser Power | <1 mW | <1 mW |
| Aiming Wavelength | 635 -0/+10 nm (appears as -5/+10 nm in new device table) | 635 -5/+10 nm |
| Aiming Laser Safety Class | 2/II | 2/II |
| Mains Electrical Supply Voltage | 90-240VAC; 250VA | 90-240VAC; 250VA |
| Supply Frequency | 50/60Hz | 50/60Hz |
| Weight (Console) | 14.5 kg | 14.5 kg |
| Weight (Slit Lamp) | 10.5 kg | 10.5 kg |
| Console Dimensions | H140 x W280 x D350 mm | H140 x W280 x D350 mm |
| Operating Temperature Range | +10 C to +40 C; RH 10 to 85% | +10 C to +40 C; RH 10 to 85% |
| Transport & Storage Temperature Range | -20 C to +60 C; RH 10% to 85% | -20 C to +60 C; RH 10% to 85% |
| Cooling (console) | Air cooled with integrated active thermo-electric cooler | Air cooled with integrated active thermo-electric cooler |
| Delivery Devices & Accessories | Ellex LIO, Standard Footswitch, Remote Control, Moveable eye safety filter | Substantially Equivalent (same as predicate) |
Note on "Acceptance Criteria": The primary "acceptance criteria" for a 510(k) submission are demonstrating that the new device (Integre LP561) is substantially equivalent to a legally marketed predicate device (Integre Duo LP1RG) in terms of intended use, technological characteristics, and performance. The modification (yellow wavelength) is justified by its clinical benefits (high absorption by melanin, high absorption by hemoglobin, no absorption in macular xanthophylls, higher transmission through cloudy media) without introducing new questions of safety or effectiveness.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This a 510(k) submission for a modified laser device, not a diagnostic AI device requiring a "test set" in the context of image analysis. The submission primarily relies on design verification and validation testing of the new laser's technical specifications and safety standards, as well as a comparison to an existing predicate device. No patient-specific "test set" data (e.g., images for diagnostic evaluation) is mentioned for this type of device. The data provenance would be internal engineering and quality assurance testing, likely conducted by Ellex Medical Pty. Ltd. in Australia.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable. This device is an ophthalmic laser for treatment, not a diagnostic device requiring expert interpretation for ground truth establishment.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. See point 3.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a therapeutic laser device, not a diagnostic AI system for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a therapeutic laser device. Its performance is evaluated based on its physical properties (wavelength, power, spot size, safety) and its demonstrated ability to achieve its intended clinical effect through photocoagulation, which is user-controlled.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For a therapeutic laser device like this, "ground truth" would relate to its functional performance and safety. This involves:
- Engineering specifications and measurements: Verifying that the laser emits the specified wavelength, power, and operates within safety limits.
- Biocompatibility and sterilization validation: Ensuring materials are safe for patient contact and the device can be properly sterilized.
- Electrical safety and electromagnetic compatibility (EMC) testing: Conforming to relevant medical device standards.
- Clinical context based on predicate: The historical clinical use and efficacy of the predicate device (Integre Duo LP1RG) and similar lasers establish the "ground truth" for the principle of photocoagulation for the indicated conditions. The new device's yellow wavelength is presented as a beneficial modification to this established principle.
No specific patient outcomes data or pathology "ground truth" from a new clinical study is detailed in this 510(k) summary; rather, the safety and effectiveness are established through technological comparison to the predicate.
8. The sample size for the training set
Not applicable. This is a therapeutic laser device, not an AI system that requires a "training set."
9. How the ground truth for the training set was established
Not applicable. See point 8.
{0}------------------------------------------------
MAR 1 1 2008
Image /page/0/Picture/1 description: The image shows a logo with the word "ellex" in white letters against a textured, dark circular background. The texture of the background appears to be made up of many small, closely spaced lines or dots, giving it a slightly rough or grainy appearance. The font used for "ellex" is simple and sans-serif, making the word easily readable despite the busy background.
82 Gilbert Street Adelaide SA, 5000 Australia ellex.com +61 3 8104 5200 +61 8 3221 5551
Attachment 5: 510(k) Summary *Submitter's Name:
Submitter's Address:
Contact Person:
Contact Details:
Date Summary Prepared:
Trade Name of Modified Device: (For which this Special 510(k) is being submitted)
Common Name of Modified Device: (For which this Special 510(k) is being submitted)
Classification of Device:
Trade Name of Predicate Device:
Common of Predicate Device:
Classification of Device:
Description of the Device:
Special 510(k)
Ellex Medical Pty. Ltd. *Manufacturing and packaging.
82 Gilbert Street Adelaide, South Australia, 5000 AUSTRALIA
Kevin Howard, Senior Regulatory Officer
Tel +61 8 8104 5200 Fax +61 8 8221 5645 Email: khoward@ellex.com
December 13, 2007
Integre LP561
Photocoagulator Ophthalmic Laser
Class II, HQF; GEX, Ophthalmic Laser
Ellex Integre Duo LP1RG
Photocoagulator Ophthalmic Laser
Class II, Ophthalmic Laser
The Integre LP561 is an addition to the Ellex range of ophthalmic photocoagulators. The Integre family are designed for use by ophthalmologists in a clinic or outpatient facility, or in the Retinal Specialist's office.
The Integre Duo LP1RG device is capable of producing focused pulses of red or green light with wavelengths of 670 nanometres (nm) and 532 nm respectively. The red and green beams may be used for the same treatments, but the red gives increased penetration of haemorrhaging tissue and fluids, and may also be used to treat ocular melanomas.
The Integre LP561 is essentially the same device with a modification to the laser cavity optical components which results in a vellow (561 nm) treatment laser output.
The reason for developing the new device is because the yellow wavelength is characterised by high absorption by melanin in the retinal pigment epithelium and choroids that reduces the
{1}------------------------------------------------
Image /page/1/Picture/0 description: The image shows a logo for "ellex" inside of a circle. The word "ellex" is written in white, sans-serif font. The circle surrounding the word is black and white and appears to be made of many small lines. The logo is simple and modern.
82 Giberi Street Adelaide SA, 5000 Australia ���������� +61 8 2104 5200 +61 8 8221 5651
penetration depth of the beam in the choroids, high absorption by haemoglobin that facilitates direct treatment for retinal/choroidal neovascularisation and no absorption in macular xanthophylls and higher transmission through cloudy media such as cataract or haze on the cornea.
As with the Integre LP1RG, the laser pulses are accurately positioned on a structure within the patient's eye with the aid of a delivery device. The delivery device is an integrated slit-lamp microscope. An optional Laser Indirect Ophthalmoscope (LIO) can also be used.
The Integre Duo is a ophthalmic photocoagulator laser designed to be used by ophthalmologists for treatment of ocular pathology of the eye. It is expected that the user is trained in operation of the instrument. This is the same intended use as previously cleared for Integre Duo laser 510(k) K052777
The Indications for Use statement can be found in Attachment 2
Refer to the following tables for a comparison of the Integre LP561 with the Integre Duo LP1RG and other commercially available predicate devices
Intended Use:
Comparison of Technological Characteristics:
{2}------------------------------------------------
| Characteristic compared | Integre LP561 | Integre Duo LP1RG;510(k) K052777 | Lumenis Novus Varia;510(k) K022181 | Nidek MC-7000;510(k) K974732 | Nidek MC-300;510(k) K042785 |
|---|---|---|---|---|---|
| Laser Type | True CW Diode-Pumped Solid-State (DPSS) | True CW Diode-Pumped Solid-State (DPSS) | Diode-Pumped Solid-State (DPSS) | Diode-Pumped Solid-State (DPSS) frequency-doubled YAG | Diode-Pumped Solid-State (DPSS) frequency-doubled YAG |
| Laser Wavelength | 561 nm (yellow) | 532 nm (green)670 nm (red) | 532 nm (green)561 nm (yellow)659 nm (red) | 520.8-530.9 nm (green)568.2 nm (yellow)647.1 nm (red) | 532 nm (green)561 nm (yellow)659 nm (red) |
| Laser Power | 50-1500 mW (yellow) | 50-2000 mW (green)50-1500 mW (red) | 50-1500 mW (green)50-600 mW (yellow)50-600 mW (red) | 50-900 mW (green)50-1500 mW (yellow/green)50-1000 mW (red) | 50-2000 mW (green)50-700 mW (yellow)50-700 mW (red) |
| Exposure time settings (pulse duration) | 0.01 to 4.0 seconds adjustable in variable increments | 0.01 to 4.0 seconds adjustable in variable increments | 0.01 to 3.0 seconds adjustable in variable increments | 0.02 seconds to continuous adjustable in 21 increments | 0.01 to 3.0 seconds adjustable in variable increments |
| Repeat mode Intervals | 0.1 to 1.0 seconds | 0.1 to 1.0 seconds | 0.05 to 3.0 | 0.2 to 1.0 seconds | 0.2 to 1.0 seconds |
| Laser Safety Class | 4/IV | 4/IV | 4/IV | 4/IV | 4/IV |
| Spot Size | 50 to 1000 µm | 50 to 1000 µm | 50 to 1000 µm | 50 to 1000 µm parfocal, 1000 to 2000 um defocused | 50 to 900 µm |
す
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. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
82 Gilbert Bireet
Adalalde SA, 6000 Australia
elleralde SA, 6000 Australia
-ﺴﺎ T, -
| Characteristic compared | Comparison Table - Aiming lasers of devices | ||||
|---|---|---|---|---|---|
| Integre LP561 | Integre Duo LP1RG | Lumenis Novus Varia | Nidek MC-7000 | Nidek MC-300 | |
| Aiming Laser Type | Semi conductor laser diode | Semi conductor laser diode | Semi conductor laser diode | Semi conductor laser diode | Diode pumped solid-state |
| Aiming Laser Power | <1 mW | <1 mW | <1 mW | <1 mW | 0.3-0.7 mW Red0.05-0.15 mW Yellow/Green |
| Aiming Wavelength | $635 -5/+10$ nm | $635 -5/+10$ nm | 635 nm | 670 nm | 532/561/659 nm |
| Laser Safety Class | 2/II | 2/II | 2/II | 2/II | 2/II |
| Characteristic compared | Comparison Table - Electrical and Mechanical Characteristics of Devices | ||||
| Integre LP561 | Integre Duo LP1RG | Lumenis Novus Varia | Nidek MC-7000 | Nidek MC-300 | |
| Mains Electrical Supply Voltage | 90-240VAC; 250VA | 90-240VAC; 250VA | 100VAC, 120VAC or 230VAC; 880VA | 90-245 VAC, 3 phase | 100/115/230 VAC |
| Supply Frequency | 50/60Hz | 50/60Hz | 50/60Hz | 50/60Hz | 50/60Hz |
| Weight | console 14.5 kgslit lamp 10.5 kgConsole H140 x W280 x D350 mm | console 14.5 kgslit lamp 10.5 kgConsole H140 x W280 x D350 mm | 52.2 kgH1020 x W460 x D640mm | 176 kgConsole 406 x 990 x 1219 mm | 75 kgConsole H780 x W350 x D725 mm |
| Operating Temperature Range | +10 C to +40 C; RH 10 to 85% | +10 C to +40 C; RH 10 to 85% | 10 C to 37°C; RH 90% @ 37 C non-condensing | 15-30°C, RH 30-75% non-condensing | |
| Transport & Storage Temperature Range | -20 C to +60 C; RH 10% to 85% | -20 C to +60 C; RH 10% to 85% | -10 C to 55°C; RH 90% @ 55°C non-condensing | 0-50°C, RH 5-95% non-condensing | |
| Cooling (console) | Air cooled with integrated active thermo-electric cooler | Air cooled with integrated active thermo-electric cooler | Forced air with integrated Thermo Electric Cooler | Internal Water Cooling | Digital control cooling device (internal water cooling) |
| Integre LP561 | Integre Duo LP1RG | Lumenis Novus Varia | Nidek MC-7000 | Nidek MC-300 | |
| Comparison Table –Delivery Devices & AccessoriesDelivery Device | |||||
| Slit LampDelivery System(SDS) | Treatment & aiminglasers integrated intoslit lamp microscope. | Treatment & aiminglasers integrated intoslit lamp microscope. | LaserLink Z andLaserLink Z-1000- slit-lamp delivery adaptors | May be used with;Nidek SL1600, ZeissSL130, Haag Striet900BQ | May be used with;- Nidek slit lampdelivery unit (SL-1800type)- Nidek attachable slitlamp delivery unit(attachable to SL-1600)- Zeiss slit lampdelivery unit(attachable to 30SL/Mtype) |
| Laser IndirectOphthalmoscope(LIO) | Ellex LIO. | Ellex LIO. | Keeler, Heine | BIO (Heine or Keeler),MIO (Neitz) | BIO (Keeler) |
| Endo OcularLaser Probe | Not available | Not available | Acculite angled,straight, illuminatingand aspirating probes | Endophotocoagulationprobe, straight,angled, illuminated &combined | Endophotocoagulationprobe, straight,angled, illuminated &combined |
| Accessory | Integre LP561 | Integre Duo LP1RG | Lumenis Novus Varia | Nidek MC-7000 | Nidek MC-300 |
| Footswitch | Standard footswitchprovided as astandard systemcomponent.Power controlfootswitch accessoryavailable. | Standard footswitchprovided as astandard systemcomponent.Power controlfootswitch accessoryavailable. | Provided as astandard systemcomponentSmart & Powereasefootswitch accessoryavailable | Provided as astandard systemcomponent | Provided as astandard systemcomponentPower Controlfootswitch accessoryavailable |
| Remote Control | Provided as astandard systemcomponent. | Provided as astandard systemcomponent. | Remote control | Provided as astandard systemcomponent | Provided as astandard systemcomponent |
| Safety Filter | Moveable eye safetyfilter. | Moveable eye safetyfilter. | Dual physician filters | Fixed colour balancedsafety filter provided asstandard systemcomponent | Provided as astandard systemcomponent |
Special 510(k)
:
15
{4}------------------------------------------------
Special 510(k)
B2 Gilberi Stroet
Arielaide SA, 5D00 Australia
. . . . . . .
: 16
{5}------------------------------------------------
assess of andications for User of Carona Escorts Estatus Estations
Comparison - Indications for User of Devices
Comparison - Includications for User of Devices
Provinces 2 Gilbert Street
Dalaide SA, 5000 Austra
ntegre LP56
The Ellex Integre is indicated for
use in photocoagulation of both
anterior and posterior segments
of the eye including:
-
- ും വേണ്ടുവരുന്നു. അവലംബം
പുറത്തുവരുന്നു വാഹ്യമായ വരുവന്തും വേണ്ടു.
അവലംബം പുറത്തേക്കും
അവലംബം പുറത്തേക്കും കാണുക
അവലംബം പുരസ്കാരം കോട്ടുകളുടെ കാലാക്കും
അവലംബം പ്രശ - dotomy, iridectomy,
turelysis and
abeculoplastly in angle
osuloplasty in angle
osure glaucoma and ope
glaure glaucoma
do Finand Santa and Santa and Sanara and
Lumenis Novuss Varia
Roomania National Paria
Roomania Rasmissioni Rasmiy Rasmiy Roomania
Norganization Maria Rasmiy
Na Bhotosto avitreal
-
-
សាសនា សាសនា សាសនា សាសនា សាសនា សាសនា សាសនា សាន ស្រុក
- ridotomy, iridectorny and and
abeculoplasty in angle close
aucoma and open and open angle glaucoma
ുക്കുന്നത്.
അവലംബം
പുറത്തിനു വാഹിത്യ വിശ്വാസിക്കുന്നു.
അവലംബം Photocoagulatio
Trabeculoplasty
or open angle
ונים המקום מקום משופיים מוספים מוספים מוסימים של משום של משום של משום של משום של משום של משום של משום של משום של משום של משום של משום של משום של משום של משמעות של משמעות של hotocoagulatii
idotomy and
rabeculoplasty
{6}------------------------------------------------
Image /page/6/Picture/1 description: The image shows the seal of the Department of Health & Human Services (USA). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, on the right side. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ellex Medical Pty. Ltd. c/o Kevin Howard Senior Regulatory Officer 82 Gilbert Street Adelaide, SA 5000 Australia
MAR 1 1 2008
Re: K080423
Trade/Device Name: Integre LP561 Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic laser Regulatory Class: Class II Product Code: HQF, GEX Dated: February 13, 2008 Received: February 15, 2008
Dear Mr. Howard:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
{7}------------------------------------------------
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Malina B. Egleston, ind
Malvina B. Eydelman, M. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{8}------------------------------------------------
Indications for Use Statement
510(k) Number (if known):
Device Name: Ellex Integre LP561 ophthalmic laser.
Indications for Use:
The Ellex Integre is indicated for use in photocoagulation of both anterior and posterior segments of the eye including:
- Retinal photocoagulation and pan retinal photocoagulation of vascular and structural . abnormalities of the retina and choroid including:
- proliferative and nonproliferative diabetic retinopathy; -
- choroidal neovascularization; -
- branch retinal vein occlusion; ।
- age-related macular degeneration;
- retinal tears and detachments: -
- retinopathy of prematurity; -
- Iridotomy, iridectorny, suturelysis and trabeculoplasty in angle closure glaucoma and open . angle glaucoma
Prescription Use V AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (OD
Dexingler 3/10/2008
510(k) Number K080423
§ 886.4390 Ophthalmic laser.
(a)
Identification. An ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin by a laser beam.(b)
Classification. Class II.