Product code HLZ— Ophthalmic

FDA has cleared 11 devices under product code HLZ between 1976 and 2026, filed by 10 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.

• 20261 clearance
• 20231 clearance
• 19971 clearance
• 19941 clearance
• 19921 clearance
• 19851 clearance
• 19831 clearance
• 19822 clearances
• 19781 clearance
• 19761 clearance

• Retmap, Inc.2 clearances
• Universo S.A.1 clearance
• Tomey Corporation USA1 clearance
• Thomasville Medical Assoc.1 clearance
• Sauquoit Industries, Inc.1 clearance
• Nicolet Biomedical Instruments1 clearance
• Lkc Technologies, Inc.1 clearance
• Life-Tech Instruments, Inc.1 clearance
• Doran Instruments, Inc.1 clearance
• Cadwell Laboratories, Inc.1 clearance

• K253586 — RM Electrode (RMH 25-01)Retmap, Inc.·2026-04-01
• K232273 — RM Electrode (RMH 23-01)Retmap, Inc.·2023-12-07
• K961805 — TOMEY DTL ELECTRODETomey Corporation USA·1997-05-09
• K926540 — SOPHER AND BIERER OVUM FORCEPSThomasville Medical Assoc.·1994-02-25
• K913239 — GOLDLENS(TM)Doran Instruments, Inc.·1992-01-31
• K844409 — DTL ELECTRODESauquoit Industries, Inc.·1985-02-14
• K830557 — ERG-JET ELECTRODEUniverso S.A.·1983-03-31
• K820254 — GOLD FOIL ERG ELECTRODESCadwell Laboratories, Inc.·1982-04-09
• K813399 — ERG-JET ELECTRODENicolet Biomedical Instruments·1982-01-22
• K781476 — MULAR GOLD LEAF ELECTRODE MODEL 7501Life-Tech Instruments, Inc.·1978-11-15
• K760199 — ELECTRORETINOGRAPHLkc Technologies, Inc.·1976-08-04