Product code HLM— Ophthalmic

FDA has cleared 16 devices under product code HLM between 1978 and 1994, filed by 12 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

• 19943 clearances
• 19935 clearances
• 19921 clearance
• 19881 clearance
• 19862 clearances
• 19801 clearance
• 19792 clearances
• 19781 clearance

• R.H. Burton Co.3 clearances
• Nidek, Inc.2 clearances
• Marco Ophthalmic, Inc.2 clearances
• Zeiss Humphrey System1 clearance
• Woodlyn, Inc.1 clearance
• Smr1 clearance
• Rodenstock Instrument Corp.1 clearance
• Leica, Inc.1 clearance
• Intermedics, Inc.1 clearance
• Hoya Corp. USA1 clearance

• K944022 — LENSCHEKLeica, Inc.·1994-11-17
• K940997 — AL-3300Hoya Corp. USA·1994-09-29
• K936199 — AUTOMATIC LENSOMETERCanon USA, Inc.·1994-09-28
• K930441 — MARCO STANDARD LENSMETERS 101,201Marco Ophthalmic, Inc.·1993-07-06
• K930445 — MARCO LM-770 DIGITAL PROJECTION LENSMETERMarco Ophthalmic, Inc.·1993-06-21
• K924776 — BURTON LENSMETER - MODEL 2021R.H. Burton Co.·1993-04-05
• K924785 — BURTON RADIUSGAUGE - MODEL 2030R.H. Burton Co.·1993-04-05
• K924788 — BURTON LENSMETERR.H. Burton Co.·1993-04-05
• K920861 — WOODLYN CLASSIC LENSMETERWoodlyn, Inc.·1992-07-30
• K884188 — NIDEK LM-870 AUTOMATIC LENSMETERNidek, Inc.·1988-11-23
• K862518 — BAUSCH & LOMB VERTOMETER V-5Bausch & Lomb, Inc.·1986-08-11
• K861064 — LM-850 AUTOMATIC LENSMETERNidek, Inc.·1986-04-15
• K801767 — DIMENSION I REFRACTION SYSTEMSmr·1980-09-16
• K791521 — VERI-VU LENSOMETERIntermedics, Inc.·1979-10-30
• K782096 — INSTRUMENTS, OVERREFRACTION SYSTEMZeiss Humphrey System·1979-01-26
• K781440 — LENSOMETER MODEL 11Rodenstock Instrument Corp.·1978-09-07