(277 days)
Not Found
No
The device description focuses on hardware components and predefined scanning patterns, with no mention of AI or ML for image analysis, decision making, or adaptive treatment.
Yes.
The device is intended for use in the treatment of various ocular pathologies through retinal photocoagulation and iridotomy/trabeculoplasty, which are therapeutic interventions.
No
Explanation: The device is described as a "laser system accessory intended for use in the treatment of ocular pathology," functioning as a "delivery system" for therapeutic laser treatment. It adjusts laser settings and positions beams, which are functions related to treatment, not diagnosis.
No
The device description clearly outlines multiple hardware components: the ArrayTM LaserLinkTM module, Console, Touchscreen display, and Remote touchpad. It is a delivery system that adapts a slit lamp and integrates with existing laser systems.
Based on the provided information, the Lumenis® Array™ LaserLink™ device is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is a laser system accessory for the treatment of ocular pathology. IVD devices are used for the diagnosis of diseases or conditions by examining specimens taken from the human body (like blood, urine, tissue).
- Device Description: The description details a system that delivers a laser beam to target tissue within the eye for therapeutic purposes. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing specimens, detecting analytes, or providing diagnostic information. The device is used to directly treat the eye with laser energy.
Therefore, the Lumenis® Array™ LaserLink™ device is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Lumenis® Array™ LaserLink™ device is a laser system accessory intended for use in the treatment of ocular pathology.
- For the posterior segment, the Lumenis® ArrayTM LaserLink™ device is indicated for use in retinal photocoagulation and panretinal photocoagulation of vascular and structural abnormalities of the retina and choroid including:
- o Proliferative and severe and very severe nonproliferative diabetic retinopathy
- o Macular edema associated with proliferative or nonproliferative diabetic retinopathy
- o Choroidal neovascularization
- o Retinal neovascularization associated with retinal occlusive disease (Branch retinal vein occlusion; Central retinal vein occlusion)
- o Macular edema associated with Branch retinal vein occlusion
- o Retinal tears and detachments
- And anterior segments as follows:
- o Iridotomy in closed angle glaucoma
- o Trabeculoplasty in open angle glaucoma
The Lumenis Laser Systems compatible for connection with the Lumenis® Array™ LaserLink™ device are:
- Novus Spectra™ Laser System (K022327)(532nm)
- Novus Spectra™ Dual Port Laser System (K022327)(532nm)
- Vision One™ Laser System (K111213)(532nm, 577nm, 659nm)
Table 2 Pattern Indications For Use
Posterior segment: Retina
Proliferative Diabetic Retinopathy, Panretinal Photocoagulation, Pattern Selection Option: Yes, Specific Pattern: All patterns except circle/half circle arc
Severe and Very Severe Non-Proliferative Diabetic Retinopathy, Panretinal Photocoagulation, Pattern Selection Option: Yes, Specific Pattern: All patterns except circle/half circle arc
Macular Edema associated with Proliferative or Non-Proliferative Diabetic Retinopathy, Focal Photocoagulation, Pattern Selection Option: No, Specific Pattern: Single Spot (no pattern)
Macular Edema associated with Proliferative or Non-Proliferative Diabetic Retinopathy, Grid Photocoagulation, Pattern Selection Option: Yes, Specific Pattern: Square, arc, line
Retinal neovascularization associated with Retinal Occlusive Disease (Branch Retinal Vein Occlusion; Central Retinal Vein Occlusion), Panretinal Photocoagulation, Pattern Selection Option: Yes, Specific Pattern: All patterns except circle/half circle arc
Macular Edema associated with Branch Retinal Vein Occlusion, Grid Photocoagulation, Pattern Selection Option: Yes, Specific Pattern: Square, arc, line
Retinal Tears and Detachments, Laser Retinopexy, Pattern Selection Option: Yes, Specific Pattern: Circle, half circle, quarter circle
Choroidal Neovascularization, Focal Laser, Pattern Selection Option: No, Specific Pattern: Single Spot (no pattern)
Anterior Segment: Glaucoma
Primary Open-Angle Glaucoma, Trabeculoplasty, Pattern Selection Option: No, Specific Pattern: Single Spot (no pattern)
Closed Angle Glaucoma, Iridotomy, Pattern Selection Option: No, Specific Pattern: Single Spot (no pattern)
Product codes (comma separated list FDA assigned to the subject device)
HQF
Device Description
The Lumenis® Array™ LaserLink™ device is a delivery system that adapts an examination slit lamp for use as a therapeutic laser delivery system, utilizing a scanning pattern generator to deliver predefined patterns of treatment. The Lumenis® Array™ LaserLink™ device is comprised of the following components:
- ArrayTM LaserLink™M module.
- Console
- Touchscreen display
- Remote touchpad
The Array™ LaserLink™ module attaches to the slit lamp and delivers the treatment beam to the target tissue.
The console houses the control electronics and power supply, and integrates the Array™ LaserLinkTM module with the laser system.
The touchscreen display is used to adjust laser treatment settings, such as laser mode, energy, and aiming beam intensity. It can be positioned on either side of the slit lamp, and duplicates the functions of the laser's remote control.
The touchpad is used to micromanipulate the position of the aiming and treatment beams, adjust laser power, spot size, the number of spots, and pattern parameters.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ocular
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)
The appropriate testing, including safety, performance and functional testing, to determine substantial equivalence has been conducted for the subject Lumenis® Array™ LaserLink™ device. IEC Testing has been completed and reports received. The Test Reports use the colloquial name of Scanning LaserLink™ rather than the determined trade name of Array™ LaserLinkTM.
The subject Array™ LaserLink™ product has been subjected to outside independent laboratory testing regarding electrical safety & EMC requirements per governing IEC 60601 Series, been subjected to side-by-side comparative performance assessment to competitive products, and has undergone protocol governed verification & validation to ensure the subject product met all determined design specifications and was substantially equivalent to named predicates. As a result, Lumenis verifies that all established testing criteria and product performance specifications have been duly met, demonstrating that equivalent indications for use, safety compliance, similar design features, functional characteristics, fundamental technology features, technical applications, service similar indications for use, and general modes of operation are substantially equivalent to cited predicate devices.
Based on the indications for use, technological characteristics, and safety and performance testing, the subject Array™ LaserLink™ product meets the minimum requirements that are considered adequate for its intended use and is substantially equivalent in design, materials, technical features, service of similar indications for use, principles of operation and indications for use to current commercially available scanners/cited predicates.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Nidek Multicolor Scan Laser Photocoagulator MC-500 Vixi (#K111493), Topcon PASCAL Streamline 577 (#K111108), Topcon (OptiMedica) PASCAL Streamline Photocoagulator (#K100019), Lumenis Vision One Laser System (#K111213)
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
§ 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.
0
ડ. 510(k) SUMMARY
510(k) Summary
NOV 0 1 2013
I. Submitter General Information:
| Device Owner Name: | Lumenis, Inc. |
|---|---|
| Address: | 3959 West 1820 South |
| Salt Lake City, UT 84104 | |
| Contact: | Jace R. McLane |
| Phone: | 801-656-2328 |
| Fax: | 801-656-2415 |
| Date of Preparation: | March 1, 2013 |
| Device Name: | |
| Trade Name: | Lumenis ® ArrayTM LaserLinkTM |
Common/Usual Name(s): Surgical Laser Class: Class II Classification Name(s): HQF, Laser, Ophthalmic CFR Reference: 21 CFR § 886.4390, Ophthalmic Laser
III. Predicate Device Name(s):
II.
Nidek Multicolor Scan Laser Photocoagulator MC-500 Vixi Trade Name(s): (#K111493). Topcon PASCAL Streamline 577 (#K111108). Topcon (OptiMedica) PASCAL Streamline Photocoagulator (#K100019) Lumenis Vision One Laser System (#K111213)
IV. Device Description:
The Lumenis® Array™ LaserLink™ device is a delivery system that adapts an examination slit lamp for use as a therapeutic laser delivery system, utilizing a scanning pattern generator to deliver predefined patterns of treatment. The Lumenis® Array™ LaserLink™ device is comprised of the following components:
- ArrayTM LaserLink™M module .
- . Console
- . Touchscreen display
- Remote touchpad .
The Array™ LaserLink™ module attaches to the slit lamp and delivers the treatment beam to the target tissue.
The console houses the control electronics and power supply, and integrates the Array™ LaserLinkTM module with the laser system.
T. 801-656-2300 F. 801-656-2415 www.lumenis.com
Image /page/0/Picture/19 description: The image shows the word "LUMENIS" in a stylized font. To the left of the word is a circular graphic with lines inside. The word "LUMENIS" is in all capital letters, and there is a small circle above and to the right of the "S". The image is in black and white.
1
The touchscreen display is used to adjust laser treatment settings, such as laser mode, energy, and aiming beam intensity. It can be positioned on either side of the slit lamp, and duplicates the functions of the laser's remote control.
The touchpad is used to micromanipulate the position of the aiming and treatment beams, adjust laser power, spot size, the number of spots, and pattern parameters.
V. Intended Use:
Device Name: Lumenis® Array™ LaserLinkTM
Indications for Use:
The Lumenis® Array™ LaserLink™ device is a laser system accessory intended for use in the treatment of ocular pathology.
- For the posterior segment, the Lumenis® ArrayTM LaserLink™ . device is indicated for use in retinal photocoagulation and panretinal photocoagulation of vascular and structural abnormalities of the retina and choroid including:
- o Proliferative and severe and very severe nonproliferative diabetic retinopathy
- o Macular edema associated with proliferative or nonproliferative diabetic retinopathy
- o Choroidal neovascularization
- o Retinal neovascularization associated with retinal occlusive disease (Branch retinal vein occlusion; Central retinal vein occlusion)
- o Macular edema associated with Branch retinal vein occlusion
- o Retinal tears and detachments
- And anterior segments as follows: .
- o Iridotomy in closed angle glaucoma
- o Trabeculoplasty in open angle glaucoma
The Lumenis Laser Systems compatible for connection with the Lumenis® Array™ LaserLink™ device are:
- Novus Spectra™ Laser System (K022327)(532nm) .
- Novus Spectra™ Dual Port Laser System (K022327)(532nm) .
- . Vision One™ Laser System (K111213)(532nm, 577nm, 659nm)
Table 2 Pattern Indications For Use
| Condition | Treatment | Pattern
Selection
Option | Specific
Pattern |
|------------------------------------|-----------------------------|--------------------------------|--------------------------------------------------|
| Posterior segment: Retina | | | |
| Proliferative Diabetic Retinopathy | Panretinal Photocoagulation | Yes | All patterns
except circle/half
circle arc |
LUMENIS®
2
| Severe and Very Severe Non-
Proliferative Diabetic Retinopathy | Panretinal Photocoagulation | Yes | All patterns
except circle/half
circle arc | | | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|-----|--------------------------------------------------|--|--|--|
| Macular Edema associated with
Proliferative or Non-Proliferative | Focal Photocoagulation | No | Single Spot (no
pattern) | | | |
| Diabetic Retinopathy | Grid Photocoagulation | Yes | Square, arc, line | | | |
| Retinal neovascularization associated Panretinal Photocoagulation
with Retinal Occlusive Disease
(Branch Retinal Vein Occlusion;
Central Retinal Vein Occlusion) | | Yes | All patterns
except circle/half
circle arc | | | |
| Macular Edema associated with
Branch Retinal Vein Occlusion | Grid Photocoagulation | Yes | Square, arc, line | | | |
| Retinal Tears and Detachments | aser Retinopexy | Yes | Circle, half
circle, quarter
circle | | | |
| Choroidal Neovascularization | Focal Laser | No | Single Spot (no
pattern) | | | |
| Anterior Segment: Glaucoma | | | | | | |
| Primary Open-Angle Glaucoma | Trabeculoplasty | No | Single Spot (no
pattern ) | | | |
| Closed Angle Glaucoma | Iridotomy | No | Single Spot (no
pattern) | | | |
VI. Substantial Equivalence Summary:
The Lumenis® Array™ LaserLink™ device has equivalent intended use as the identified predicate device - Nidek Multicolor Scan Laser Photocoagulator MC-500 Vixi (#K111493), Topcon PASCAL Streamline 577 (#K111108), Topcon (OptiMedica) PASCAL Streamline Photocoagulator (#K100019); and Lumenis Vision One Laser System (#K111213), and also employs the same fundamental scientific technology as the identified predicate devices. In addition, the subject device, Lumenis® Array™ LaserLink™, and the predicate devices service similar indications for use, equivalent principles of operation, method of energy delivery, critical materials, and basal design elements when directly compared.
| Table 2 510(k) Summary Predicate Comparison | |||
|---|---|---|---|
| -- | -- | -- | --------------------------------------------- |
| | Predicate
Device | Predicate
Device | Predicate Device | Predicate Device | Subject Device |
|----------------------|---------------------------------|--------------------------------------------------|-----------------------------------------------------------------------------|--------------------------------------------------|---------------------------------------------|
| Charact-
eristics | K111493
Nidek MC-500
Vixi | K111108
Topcon
PASCAL
Streamline
577 | K100019
Topcon
/OptiMedica
PASCAL
Streamline
Photocoagulator | K111213
Lumenis Vision
One Laser
System | K130195
Lumenis®
Array™
LaserLink™ |
| Treatment λ | 532nm, 577nm,
& 647nm | 577nm | 532nm | 532nm, 577nm,
659nm | 532nm, 577nm, &
659nm |
Lumenis, Inc. 3959 West 1820 South Salt Lake City, Utah 84104
T. 801-656-2300 F.801−656−2415 www.lumenis.com
Image /page/2/Picture/8 description: The image shows the word "LUMENIS" in a stylized font. The first two letters, "LU", are combined into a single symbol that resembles a circle with a vertical line through it. The rest of the letters are spaced out evenly and are in a bold, sans-serif font. There is a small circle above and to the right of the "S".
3
| | Predicate
Device | Predicate
Device | Predicate
Device | Predicate Device | Subject Device |
|-------------------------------------|-------------------------------------------------------------------------|-----------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|
| Charact-
eristics | K111493
Nidek MC-500
Vixi | K111108
Topcon
PASCAL
Streamline
577 | K100019
Topcon
/OptiMedica
PASCAL
Streamline
Photocoagulator | K111213
Lumenis Vision
One Laser
System | K130195
Lumenis®
Array™
LaserLink™ |
| Laser Type | Diode Pumped
Solid State | OPSL -
Optically
Pumped Semi-
conductor
Laser | OPSL - Optically
Pumped Semi-
conductor Laser | OPSL -
Optically
Pumped Semi-
conductor Laser | OPSL - Optically
Pumped Semi-
conductor Laser |
| Power Input | 100-240 VAC | 100-240 VAC | 100-240 VAC | 100-240 VAC | 100-240 VAC |
| Display Type
& User
interface | Color LCD
panel w /
Touchscreen | Adjustable
LCD
touchscreen
control panel
(color) | Adjustable LCD
touchscreen control
panel (color) | Color LCD panel
w / Touchscreen | Color LCD panel
w / Touchscreen |
| Compatible
Lasers | Integrated:
Nidek MC-
500: 532nm,
577nm, 647nm
(Integrated) | Integrated:
Topcon
PASCAL
Streamline
577: 577nm
(Integrated) | Integrated:
Topcon /
OptiMedica
PASCAL
Streamline
Photocoagu-lator:
532nm
(Integrated) | Laser with Green
(532nm), Yellow
(577nm), & Red
(659nm)
wavelength
Single spot
delivery. | Non-Integrated:
Lumenis Vision
One: 532nm,
577nm, 659nm
Lumenis Novus
Spectra Family:
532nm |
VII. Performance Data:
The appropriate testing, including safety, performance and functional testing, to determine substantial equivalence has been conducted for the subject Lumenis® Array™ LaserLink™ device. IEC Testing has been completed and reports received. The Test Reports use the colloquial name of Scanning LaserLink™ rather than the determined trade name of Array™ LaserLinkTM.
The subject Array™ LaserLink™ product has been subjected to outside independent laboratory testing regarding electrical safety & EMC requirements per governing IEC 60601 Series, been subjected to side-by-side comparative performance assessment to competitive products, and has undergone protocol governed verification & validation to ensure the subject product met all determined design specifications and was substantially equivalent to named predicates. As a result, Lumenis verifies that all established testing criteria and product performance specifications have been duly met, demonstrating that equivalent indications for use, safety compliance, similar design features, functional characteristics, fundamental technology features, technical applications, service similar indications for use, and general modes of operation are substantially equivalent to cited predicate devices.
Lumenis, Inc. 3959 West 1820 South Salt Lake City. Utah 84104
T. 801-656-2300 F. 801-656-2415 www.lumenis.com
Image /page/3/Picture/7 description: The image shows the logo for Lumenis. The logo consists of a stylized letter 'L' in a circle, followed by the word 'LUMENIS' in all capital letters. A small circle is present above and to the right of the 'S' in 'LUMENIS'.
4
Based on the indications for use, technological characteristics, and safety and performance testing, the subject Array™ LaserLink™ product meets the minimum requirements that are considered adequate for its intended use and is substantially equivalent in design, materials, technical features, service of similar indications for use, principles of operation and indications for use to current commercially available scanners/cited predicates.
VIII. Conclusion:
The Lumenis® Array™ LaserLink™ subject device has equivalent intended use, general design, and fundamental scientific technology as the predicate devices -Nidek Multicolor Scan Laser Photocoagulator MC-500 Vixi (#K111493), Topcon PASCAL Streamline 577 (#K111108), Topcon (OptiMedica) PASCAL Streamline Photocoagulator (#K100019), and Lumenis Vision One Laser System (#K111213). There are no new hazards introduced by the Lumenis® Array™ LaserLink™M device as compared with the predicate devices.
Lumenis, Inc. 3959 West 1820 South Salt Lake City, Utah 84104 T. 801-656-2300 F. 801-656-2415 www.lumenis.com
Image /page/4/Picture/6 description: The image shows the word "LUMENIS" in a stylized font. The first letter, "L", is part of a circular design to the left of the word. There is a small superscript symbol to the right of the "S" in "LUMENIS".
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with its wings spread.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 1, 2013
Lumenis, Incorporated Mr. Jace R. McLane Regulatory Affairs Specialist 3959 West 1820 South Salt Lake City, Utah 84194
Re: K130195
Trade/Device Name: Lumenis® Array" LaserLink" Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic laser Regulatory Class: Class II Product Code: HOF Dated: October 4, 2013 Received: October 10, 2013
Dear Mr. McLane:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
6
Page 2 - Mr. Jace R. McLane
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803). please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N Melkerson -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
Indications for Use
510(k) Number: K130195
Device Name: Lumenis® Array™ LaserLink ™
The Lumenis® Array™ LaserLink™ device is a laser system accessory intended for use in the treatment of ocular pathology.
- For the posterior segment, the Lumenis® Array™ LaserLink™ device is . indicated for use in retinal photocoagulation and panretinal photocoagulation of vascular and structural abnormalities of the retina and choroid including:
o Proliferative and severe and very severe nonproliferative diabetic retinopathy
o Macular edema associated with proliferative or nonproliferative diabetic retinopathy
- o Choroidal neovascularization
o Retinal neovascularization associated with retinal occlusive disease (Branch retinal vein occlusion: Central retinal vein occlusion)
o Macular edema associated with Branch retinal vein occlusion o Retinal tears and detachments
- And anterior segments as follows: .
- o Iridotomy in closed angle glaucoma
- o Trabeculoplasty in open angle glaucoma
The Lumenis Laser Systems compatible for connection with the Lumenis® Array™ LaserLink™ device are:
- . Novus Spectra™ Laser System (K022327)(532nm)
- Novus Spectra™ Dual Port Laser System (K022327)(532nm) .
- Vision One™ Laser System (K111213)(532nm, 577nm, 659nm) .
Page 1 of 3
8
| Condition | Treatment | Pattern
Selection
Option | Specific
Pattern |
|-----------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|--------------------------------|-----------------------------------------------------|
| Posterior segment: Retina | | | |
| Proliferative Diabetic
Retinopathy | Panretinal Photocoagulation | Yes | All patterns
except
circle/half
circle arc |
| Severe and Very Severe Non-
Proliferative Diabetic
Retinopathy | Panretinal Photocoagulation | Yes | All patterns
except
circle/half
circle arc |
| Macular Edema associated
with Proliferative or Non-
Proliferative Diabetic
Retinopathy | Focal Photocoagulation | No | Single Spot
(no pattern) |
| Macular Edema associated
with Proliferative or Non-
Proliferative Diabetic
Retinopathy | Grid Photocoagulation | Yes | Square, arc,
line |
| Retinal neovascularization
associated with Retinal
Occlusive Disease (Branch
Retinal Vein Occlusion;
Central Retinal Vein
Occlusion) | Panretinal Photocoagulation | Yes | All patterns
except
circle/half
circle arc |
| Macular Edema associated
with Branch Retinal Vein
Occlusion | Grid Photocoagulation | Yes | Square, arc,
line |
| Retinal Tears and
Detachments | Laser Retinopexy | Yes | Circle, half
circle, quarter
circle |
| Choroidal Neovascularization | Focal Laser | No | Single Spot
(no pattern) |
| Anterior Segment: Glaucoma | | | |
| Primary Open-Angle
Glaucoma | Trabeculoplasty | No | Single Spot
(no pattern) |
| Closed Angle Glaucoma | Iridotomy | No | Single Spot
(no pattern) |
Table 1 Pattern Indications For Use
Page 2 of __3
・
.
9
Prescription Use __XX (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
Neil R Ogden
2013.11.01 16:14:43 -04'00'
(Division Sign-Off) for MXM Division of Surgical Devices 510(k) Number K130195_______________________________________________________________________________________________________________________________________________________
Page 3 of ___ 3_