Who is the manufacturer of PASCAL SYNTHESIS (532NM/577NM) OPTHALMIC LASER?

Topcon Medical Laser Systems, Inc. filed the 510(k) submission for PASCAL SYNTHESIS (532NM/577NM) OPTHALMIC LASER (K123542).

What is the FDA product code for PASCAL SYNTHESIS (532NM/577NM) OPTHALMIC LASER?

HQF. It is classified under 21 CFR 886.4390 as a Class 2 device in the Ophthalmic panel.

What is the regulatory pathway for PASCAL SYNTHESIS (532NM/577NM) OPTHALMIC LASER?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like PASCAL SYNTHESIS (532NM/577NM) OPTHALMIC LASER?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

PASCAL SYNTHESIS (532NM/577NM) OPTHALMIC LASER

Q: What are the predicate devices for PASCAL SYNTHESIS (532NM/577NM) OPTHALMIC LASER?

Optimedica Ophthalmic Scanning Laser System (K092621); Topcon Ophthalmic Scanning Laser System (K111108); Iridex TxCell Adaptor/Photocoagulator System (K121475).

K123542 · Topcon Medical Laser Systems, Inc. · HQF · May 15, 2013 · Ophthalmic

Device Facts

Record ID	K123542
Device Name	PASCAL SYNTHESIS (532NM/577NM) OPTHALMIC LASER
Applicant	Topcon Medical Laser Systems, Inc.
Product Code	HQF · Ophthalmic
Decision Date	May 15, 2013
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 886.4390
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The PASCAL® Synthesis Ophthalmic Scanning Laser System is intended for use in the treatment of ocular pathology in both the posterior and anterior segments. Intended for use in the posterior segment to perform retinal photocoagulation, panretinal photocoagulation, focal photocoagulation and grid photocoagulation for vascular and structural abnormalities of the retina and choroid including: (532nm) - proliferative and non-proliferative diabetic retinopathy - macular-edema - choroidal neovascularization associated with wet age-related macular degeneration - age-related macular degeneration - lattice degeneration - retinal tears and detachments (577nm) - proliferative and non-proliferative diabetic retinopathy - macular edema - choroidal neovascularization associated with wet age-related macular degeneration - age-related macular degeneration - lattice degeneration - retinal tears and detachments Intended for use in the treatment of ocular pathology in the anterior segment including: (532 nm and 577nm) - iridotomy - trabeculoplasty.

Device Story

PASCAL Synthesis is a stand-alone ophthalmic laser delivery console for use with slit lamps, LIOs, or probes. System delivers 532nm or 577nm laser energy to treat retinal/choroidal vascular/structural abnormalities and anterior segment pathologies. Operator (physician) controls system via LCD/touchscreen interface; laser activation via wired footswitch. Safety features include three-position key switch, emergency off switch, and door interlock. Device transforms electrical input into controlled laser output for photocoagulation. Clinical benefit includes precise, automated scanning delivery for retinal/anterior segment conditions. Output allows physician to perform targeted photocoagulation, iridotomy, or trabeculoplasty to manage ocular disease.

Clinical Evidence

Bench testing included electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), and software validation (EN 60601-1-4, 62304). Animal study (GLP-compliant) compared retinal lesion appearance between PASCAL Synthesis and PASCAL Streamline. Results showed comparable lesion morphology, diameter, and clinical grade, with no systematic trend in diameter differences. No clinical human data provided.

Technological Characteristics

OPSL (Optically Pumped Semiconductor Laser) technology; 532nm or 577nm wavelengths; 30-2000 mW power output; 2-1000 ms exposure time; 100% duty cycle. Includes 635nm aiming beam. Stand-alone console with LCD/touchscreen, slit lamp connector, and wired footswitch. Electrical: 100-230 VAC, 50/60 Hz. Class IV laser device.

Indications for Use

Indicated for patients requiring treatment of ocular pathology in posterior and anterior segments, including proliferative/non-proliferative diabetic retinopathy, macular edema, wet age-related macular degeneration, lattice degeneration, retinal tears/detachments, iridotomy, and trabeculoplasty.

Regulatory Classification

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.

Predicate Devices

Optimedica Ophthalmic Scanning Laser System (K092621)
Topcon Ophthalmic Scanning Laser System (K111108)
Iridex TxCell Adaptor/Photocoagulator System (K121475)

Related Devices

K043486 — PASCAL PHOTOCOAGULATOR, PRODUCT-PASCAL-01 · Topcon Medical Laser Systems, Inc. · Mar 3, 2005
K223132 — Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm and 577 nm models) · Iridex Corporation · Nov 9, 2022
K092621 — PASCAL STREAMLINE PHOTOCOAGULATOR · Topcon Medical Laser Systems, Inc. · Sep 25, 2009
K170409 — PASCAL Synthesis Twinstar Ophthalmic Scanning Laser System · Topcon Medical Laser Systems, Inc. (Tmls) · Sep 12, 2017
K123056 — PASCAL LASER INDIRECT OPHTHALMOSCOPE · Topcon Medical Laser Systems, Inc. (Tmls) · Nov 13, 2012

Submission Summary (Full Text)

{0}------------------------------------------------ # 510 (K) SUMMARY - K123542 ### General Information I. Submitter: Topcon Medical Laser Systems, Inc. 3130 Coronado Drive Santa Clara, CA 95054, USA | Contact Person: | Pamela M. Buckman | |-----------------|-----------------------| | | Regulatory Consultant | | | T 925 980 7007 | | | F 925 705 7381 | | | pmbuckman@gmail.com | May 12, 2013 Summary Preparation Date: ## Names II. | Device Name(s): | PASCAL® Synthesis™ Ophthalmic Scanning Laser System | |-------------------------|-----------------------------------------------------------------------------------------------------| | Common Name: | Laser, Ophthalmic | | Classification Name(s): | Laser Surgical Instrument for use in General and Plastic Surgery and Dermatology; Laser, Powered | ### Predicate Devices III. - Optimedica Ophthalmic Scanning Laser System (K092621) . - . Topcon Ophthalmic Scanning Laser System (K111108) - Iridex TxCell Adaptor/Photocoagulator System (K121475) . ### Product Description IV. The PASCAL® Synthesis™ Ophthalmic Scanning Laser System is a stand-alone laser delivery console for use with a slit lamp. LIO or probe delivery. Controls and displays include an I.CD/Touchscreen user interface and a slit lamp connector (SLC). The system is equipped with a three-position key switch that enables laser and controls as well as an emergency off switch. An externally connected wired footswitch activator is provided with a shrouded housing, and contains a set of redundant switches. An external door interlock connection allows the laser to be terminated with an open circuit. {1}------------------------------------------------ # V. Summary of Non Clinical Tests Topcon utilized hardware testing (60601-1, -2-x; EN ISO14971-C; ASTM 4169-09&6653-01; ASTM D4169-09). electromagnetic testing (IEC 60601-1-2. 4. 6) software testing (EN 60601-1-41 62304 and animal testing to establish a basis for the determination of equivalence. The PASCAL® Synthesis performance characteristics were established by referencing the known performance characteristics of the predicate device. Specifications for the PASCAL® Synthesis system were established to assure that the predicate system and the Synthesis system performed in an equivalent manner. Performance specifications were set utilizing national and international standards for such devices with respect to output, indications for use, safety features and electromagnetic interference where it was established as suitable for the environment of use. All testing was conducted and established that the PASCAL® Synthesis system met or exceeded its design specifications and performed equally or better than the stated performance of the predicate. The objective of the animal study was to compare the appearance of retinal laser lesions produced by the PASCAL Synthesis system with the predicate PASCAL Streamline system in an animal model. This prospective comparative study included delivery of laser lesions to two animals in accordance with Good Laboratory Practices (GLP) standards and the local Animal Institutional Review Board. Multiple lesions using varying spot sizes and intensities were created with each of the two lasers and assigned a clinical grade by the laser operator on a 5 point scale. When comparing lesions of the same clinical grades, the appearance of the lesions was similar. The diameter of the lesions was <20% in mean diameter. Within lesions of the same clinical grade, the variability was approximately 10%. Lesions were created using spot sizes of 100, 200 and 400 micron (50 micron was not part of the investigation). Powers ranged from 70 mW to 450 Endpoint Management algorithms were not used as part of this investigation. No mW. systematic trend in lesion diameter was observed. The Streamline device and the Synthesis device were comparable in a preclinical setting. Conclusions drawn from these non-clinical tests demonstrate that the device is as safe, as effective and performs at least as safely and as effectively as the legally marketed device identified in this Summary. #### VI. Indications for Use The PASCAL® Synthesis Ophthalmic Scanning Laser System is intended for use in the treatment of ocular pathology in both the posterior and anterior segments. Intended for use in the posterior segment to perform retinal photocoagulation, panretinal photocoagulation, focal photocoagulation and grid photocoagulation for vascular and structural abnormalities of the retina and choroid including: (532nm) - proliferative and non-proliferative diabetic retinopathy . - . macular-edema - choroidal neovascularization associated with wet age-related macular degeneration . - age-related macular degeneration t - . lattice degeneration - retinal tears and detachments . {2}------------------------------------------------ # (577nm) - proliferative and non-proliferative diabetic retinopathy ● - . macular edema - choroidal neovascularization associated with wet age-related macular degeneration � - age-related macular degeneration . - lattice degeneration . - . retinal tears and detachments Intended for use in the treatment of ocular pathology in the anterior segment including: (532 nm and 577nm) - iridotomy . - trabeculoplasty. . ## VII. Summary of Technological Characteristics . The technological characteristics of the PASCAL® Synthesis Ophthalmic Scanning Laser System are substantially equivalent to those of the predicate. | Technical Characteristics | K092621 | K111108 | K121475/K071687 | K123542 PASCAL® Synthesis | |--------------------------------------------------------------------|------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------| | Type of Laser | OPSL - Optically Pumped Semiconductor Laser; Diode Pumped; Solid State | OPSL - Optically Pumped Semiconductor Laser; Diode Pumped; Solid State | OPSL - Optically Pumped Semiconductor Laser; Diode Pumped; Solid State | OPSL - Optically Pumped Semiconductor Laser; Diode Pumped; Solid State | | Output Wavelength | 532 nm | 577 nm | 532 nm or 577 nm | 532 nm or 577 nm | | Power output | 0, 100 mW - 2000 mW | 0, 100 mW - 2000 mW | 0-2000 mW | 0, 30 mW - 2000 mW | | Duty cycle | 100% | 100% | Variable | 100% | | Exposure time | 5 ms - 1000 ms | 10 ms - 1000 ms | 0.05 ms - 3000 ms | 2 ms - 1000 ms | | Repetition Rate (available with single spot pattern only) | Off, 1.0hz, 1.5hz, 2.0hz, 3.0hz, 4.0hz, 5.0hz, 6.0hz, 7.0hz, 8.0hz | Off, 1.0hz, 1.5hz, 2.0hz, 3.0hz, 4.0hz, 5.0hz, 6.0hz, 7.0hz, 8.0hz | Available only with single spot pattern | Off, 1.0hz, 1.5hz, 2.0hz, 3.0hz, 4.0hz, 5.0hz, 6.0hz, 7.0hz, 8.0hz | | Pulse counter | 0 - 99,999 with Automatic reset | 0 - 99,999, reset available | Not Reported | 0 - 99,999, reset available | | CDRH Classification | Class IV | Class IV | Class IV | Class IV | | European MDD Classification | Class 4 | Class 4 | Class 4 | Class 4 | | Type | Direct diode | Direct diode | Direct diode | Direct diode | {3}------------------------------------------------ | Technical Characteristics | K092621 | K111108 | K121475/K071687 | K123542 PASCAL® Synthesis | |------------------------------|----------------------------|----------------------------|----------------------|---------------------------------| | Wavelength | 635 nm | 635 nm | 635 nm | 635 nm | | Power output | Adjustable to <1 mW | Adjustable to <1 mW | Adjustable to <1 mW | Adjustable to <1 mW | | CDRH laser Classification | Class II | Class II | Class II | Class II | | Electrical Requirements | | | | | | Voltage | 100-240 VAC ± 10% | 100-230 VAC ± 10% | 100-240 VAC ± 10% | 100-230 VAC ± 10% | | Frequency | 50/60 Hz, single- phase | 50/60 Hz, single- phase | 50/60 Hz | 50/60 Hz, single- phase | | Current | <5 Amperes | <10 Amperes | Not Reported | <10 Amperes | # VIII. Rationale for Substantial Equivalence The PASCAL® Synthesis Ophthalmic Scanning Laser System shares the same indications for use, device operation, overall technical and functional capabilities, and therefore is substantially equivalent to the predicate devices. ## IX. Safety and Effectiveness Information The review of the indications for use and technical characteristics demonstrates that the PASCAL® Synthesis Ophthalmic Scanning Laser System is substantially equivalent to the predicate devices. No new safety or effectiveness questions are applicable. ## X. Conclusion The PASCAL® Synthesis Ophthalmic Scanning Laser System was found to be substantially equivalent to the predicate devices. The PASCAL® Synthesis Ophthalmic Scanning Laser System shares the same indications for use, similar design features, and functional features with, and thus is substantially equivalent to, the predicate device. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The text is in all caps and is in a sans-serif font. # DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-002 May 15, 2013 Topcon Medical Laser Systems, Inc. % Buckman Company, Inc. Ms. Pamela M. Buckman Regulatory Consultant 2800 Pleasant Hill Road, Suite 175 Pleasant Hill, California 94553 Re: K123542 Trade/Device Name: PASCAL® Synthesis" Ophthalmic Scanning Laser System . Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic laser Regulatory Class: Class II Product Code: HQF, GEX Dated: April 15, 2013 Received: April 22, 2013 Dear Ms. Buckman: 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 {5}------------------------------------------------ Page 2 - Ms. Pamela M. Buckman 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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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, For Peter D Rumm -S Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ # Indications for Use | 510(k) Number: K123542 | | |------------------------|-----------------------------------------------------------| | Device Name: | Topcon PASCAL® Synthesis Ophthalmic Scanning Laser System | The PASCAL® Synthesis Ophthalmic Scanning Laser System is intended for use in the treatment of ocular pathology in both the posterior and anterior segments. Intended for use in the posterior segment to perform retinal photocoagulation, panretinal photocoagulation. focal photocoagulation and grid photocoagulation for vascular and structural abnormalities of the retina and choroid including: . - (532nm) - proliferative and non-proliferative diabetic retinopathy - macular edema t - choroidal neovascularization associated with wet age-related macular degeneration . - . age-related macular degeneration - . lattice degeneration - . retinal tears and detachments (577nm) - . proliferative and non-proliferative diabetic retinopathy - . macular édema - . choroidal neovascularization associated with wet age-related macular degeneration - . age-related macular degeneration - ◆ lattice degeneration - � retinal tears and detachments Intended for use in the treatment of ocular pathology in the anterior segment including: (532 nm and 577nm) - iridotomy � - trabeculoplasty . X Prescription Use (Per 21CFR 801 Subpart D) OR Over-The-Counter Use (21 CFR 801 Subpart C) · PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED # Neil R Ogdens 2013.05.15 11:05:52 -04'00' (Division Sign-Off) for MXM Division of Surgical Devices 510(k) Number K123542