Laser, Neodymium:yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary

Product Code: LOI

Medical Laser Products

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

Code of Federal Regulations:


Radiation TypeOptical
Radition SafetyProduct
Annual ReportsYes

Products Classified as LOI

4432Laser, Neodymium:yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary

Total Product Life Cycle (TPLC) Devices

4432Laser, Neodymium:yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary

FDA Consensus Standards

Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary [32410]21 CFR Unclassified 🔎
Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary [29297]21 CFR Unclassified 🔎
Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary [32150]21 CFR Unclassified 🔎

Pre-market Approvals for LOI

P850083VISULAS ND:YAG LASERCARL ZEISS, INC.
P830054NEODYMIUM: YAG OPHTHALMIC LASER SYSTEM 9900COHERENT MEDICAL DIVISION
P830062ND:YAG POSTERIOR CAPSULOTOMY MODEL 100NIDEK, INC.
P990078HYPERION LTK SYSTEMSUNRISE TECHNOLOGIES, INC.

Pre-market Notifications for LOI

K881459NANOLAS ND:YAG OPHTHALMIC LASERBIOPHYSIC MEDICAL, INC.

Maude Adverse Events

YAG LASER*2003-01-06
EPIC ICOHERENT, INC.1999-08-30
COHERENTCOHERENT MED DIVISION1998-04-17

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