Ophthalmoscope, Laser, Scanning

Product Code: MYC

Ophthalmic Medical Laser Products

Definition: Radiation Emitting Electronic Product Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Co

Applicable Standards: Laser Products. [1040.10] Specific Purpose Laser Products. [1040.11]

Code of Federal Regulations: 886.1570


Radiation TypeOptical
Radition SafetyProduct
Annual ReportsYes

Products Classified as MYC

4364Ophthalmoscope, Laser, ScanningOphthalmoscope.

Total Product Life Cycle (TPLC) Devices

4364Ophthalmoscope, Laser, ScanningOphthalmoscope.

FDA Consensus Standards

Ophthalmoscope, Laser, Scanning [29877]21 CFR §886.1570 🔎
Ophthalmoscope, Laser, Scanning [20112]21 CFR §886.1570 🔎
Ophthalmoscope, Laser, Scanning [29874]21 CFR §886.1570 🔎
Ophthalmoscope, Laser, Scanning [34468]21 CFR §886.1570 🔎

Pre-market Notifications for MYC

K211328EIDON FA, EIDON, EIDON AF, EIDON UWFLCenterVue SpA
K192113DRSplusCenterVue SpA
K180526EIDON FACenterVue SpA
K180293Retia 2CenterVue SpA
K153181MAIACENTERVUE SPA
K150320COMPASSCENTERVUE SPA
K142897P200DTxOPTOS PLC.
K142047EIDONCENTERVUE SPA
K134039DAYTONA ICG (P200TICG)OPTOS PLC
K112880CLEARPATH DS-120(R) LENS FLUORESCENCE BIOMICROSCOPEFREEDOM MEDITECH, INC.
K111988EASYSCAN MODEL 1.2I-OPTICS BV
K111628P200TOPTOS PLC
K102492P200MAAFOPTOS PLC
K100644OPTOS LIMITED PANORAMIC 200CAFOPTOS PLC
K093521GDXPROCARL ZEISS MEDITEC INC

Global Unique Device Identification Database

00849233010598Ophthalmoscope,Laser,Scanning
05057056107004Ophthalmoscope,Laser,Scanning
05057056106885Ophthalmoscope,Laser,Scanning
05057056106502Ophthalmoscope,Laser,Scanning
05057056106397Ophthalmoscope,Laser,Scanning
05057056106007Ophthalmoscope,Laser,Scanning
05057056100920Ophthalmoscope,Laser,Scanning
05057056100210Ophthalmoscope,Laser,Scanning
04987669100561Ophthalmoscope, Laser, Scanning
04987646804024Ophthalmoscope,Laser,Scanning
04059237000549Ophthalmoscope, Laser, Scanning
04059237000525Ophthalmoscope, Laser, Scanning
04059237000303Ophthalmoscope,Laser,Scanning
04059237000259Ophthalmoscope,Laser,Scanning
04059237000136Ophthalmoscope,Laser,Scanning

Maude Adverse Events

VOLKVOLK2002-09-05
NIKON OCULARNIKON2002-09-05
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