FDA.reportPublic FDA data

PACSAL Synthesis

Primary DI
00855005006249
Brand
PACSAL Synthesis
Company
TOPCON MEDICAL LASER SYSTEMS, INC.
Model
PASCAL Synthesis 532- PA04
Catalog number
SA-06454
Device description
PASCAL Synthesis (532), Green, PA-04 (PACKED)
Published
2019-09-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEXPowered laser surgical instrument
HQFLaser, ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2
HQFLaser, OphthalmicOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K123542000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123542000PASCAL SYNTHESIS (532NM/577NM) OPTHALMIC LASERTopcon Medical Laser Systems, Inc.2013-05-15HQF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00855005006249PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00855005006249008550050062498550050062490855005006249

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic solid-state laser system, photodisruptionA mains electricity (AC-powered) device assembly in which input energy is used to excite a glass/crystal rod to emit a high-power laser beam intended to cause a photodisruptive effect in the eye by forming a plasma and generating mechanical shock waves (microexplosions) that destroy tissue when highly focused (e.g., for cataract extraction, posterior capsulotomy). It typically includes a light source and controls/foot-switch and has a built-in slit lamp biomicroscope, or is coupled to a slit lamp or indirect ophthalmoscope by fixed mirrors. It does not include femtosecond pulsing, frequency doubling, or fundus imaging technology.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity085 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius55 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(888)850-1223ssrivastava@topcon.com

Regulatory Flags#

DUNS number
041376321
Device count
1
DM exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00855005006218Head-Up-Display, HUD-1Head-Up-Display,HUD-1SA-064272018-02-12
00855005006102PASCAL Laser Indirect OphthalmoscopeLIO for Streamline 532SA-061612016-04-15
00855005006119PASCAL Laser Indirect OphthalmoscopeLIO for Streamline 577SA-061622016-04-15
00855005006126PASCAL Laser Indirect OphthalmoscopeLIO for Synthesis 532SA-061712016-04-15
00855005006133PASCAL Laser Indirect OphthalmoscopeLIO for Synthesis 577SA-061722016-04-15
00855005006140PASCAL Laser Indirect OphthalmoscopeLIO for PASCAL Photocoagulator 532SA-062012016-04-15
00855005006232PASCAL Synthesis TwinStarPASCAL Synthesis TwinStar (577/638)- PA04SA-064522019-09-17
00855005006256PASCAL SynthesisPASCAL Synthesis 577- PA04SA-064552019-09-17
00855005006263PASCAL Synthesis TwinStarPASCAL Synthesis TwinStar (577/638)- PA04SA-064532019-09-17
00855005006270PACSAL SynthesisPASCAL Synthesis 532- PA04SA-064562019-09-17
00855005006287PACSAL SynthesisPASCAL Synthesis 577- PA04SA-064572019-09-17
00855005006003PASCAL SynthesisPASCAL Synthesis 532SA-062802016-04-15
00855005006010PASCAL SynthesisPASCAL Synthesis 577SA-062812016-04-15
00855005006027PASCAL SynthesisPASCAL Synthesis 532SA-062842016-04-15
00855005006034PASCAL SynthesisPASCAL Synthesis 577SA-062852016-04-15
00855005006041PASCAL SynthesisSynthesis SLC & ESF 532SA-063762016-04-15
00855005006058PASCAL SynthesisSynthesis SLC & ESF 577SA-063772016-04-15
00855005006065PASCAL SynthesisSynthesis SLC & ESF 532SA-061952016-04-15
00855005006072PASCAL SynthesisSynthesis SLC & ESF 577SA-061972016-04-15
00855005006089PASCAL SynthesisSynthesis SLC & ESF 532SA-061942016-04-15

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Primary DI, Brand, Company table
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08056389701122EPI-C PLUSESPANSIONE MARKETING SPAGEX2026-04-30
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08052049500326Splendor XBIOS SRLGEX2025-01-16
08052049500333Splendor XBIOS SRLGEX2025-01-16
08052049500340Splendor XBIOS SRLGEX2025-01-16
08052049500357Splendor XBIOS SRLGEX2025-01-16
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