Product code FSR— Ophthalmic

FDA has cleared 4 devices under product code FSR between 2000 and 2011, filed by 3 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 20111 clearance
• 20032 clearances
• 20001 clearance

• Welch Allyn, Inc.2 clearances
• Integra LifeSciences Corporation1 clearance
• Angiolaz, Inc.1 clearance

• K110528 — INTEGRA LED SURGICAL HEADLIGHT SYSTEMIntegra LifeSciences Corporation·2011-05-11
• K031548 — LED HEADLIGHTWelch Allyn, Inc.·2003-08-11
• K031549 — SOLID STATE LAMP [LED] HEADLIGHTWelch Allyn, Inc.·2003-08-11
• K994362 — HEADLAMP HL2000.Angiolaz, Inc.·2000-05-11