Product code HRM
- Device name
- Microscope, Operating & Accessories, Ac-Powered, Ophthalmic
- Medical specialty
- General, Plastic Surgery
- Device class
- 1
- Regulation number
- 878.4700
- Review panel
- SU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K932720 | HM-0970 | Hill-Med, Inc. | 1993-09-07 |
| K930439 | MARCO SURGISCOPE OPERATION MICROSCOPES | Marco Ophthalmic, Inc. | 1993-07-22 |
| K920641 | ALCON OPERATING MICROSCOPES | Alcon Laboratories | 1992-10-09 |
| K914956 | KEELER KONAN SPECULAR MICROSCOPE SP5500 | Keeler Instruments, Inc. | 1992-02-03 |
| K891584 | S 22 INSTRUMENT STAND | Carl Zeiss, Inc. | 1989-06-08 |
| K891001 | MICROSCOPE KNOB COVER, STERILE, DISPOSABLE | Prescott'S, Inc. | 1989-04-11 |
| K854440 | MODIFIED CLINICAL WIDEFIELD SPECULAR MICROSCOPE 50 | Keeler Instruments, Inc. | 1985-12-16 |
| K853855 | XTAL X-150 OPERATING MICROSCOPE | Xtal Corp. | 1985-10-15 |
| K852586 | CROMIC SURGICAL MICROSCOPE MODEL MC-1 | Seltrex, Corp. | 1985-07-30 |
| K852150 | CLINICAL WIDEFIELD SPECULAR MICRISCOPE 500 | Keeler Instruments, Inc. | 1985-06-03 |
| K850270 | CORNEAL LIGHT SHIELD | Mentor O & O, Inc. | 1985-05-31 |
| K844323 | KONAN CLINIC MICROSCOPE CLM-100-150 | Keeler Instruments, Inc. | 1984-11-21 |
| K822563 | OPHTHALMIC MICROSCOPE | Treace Medical, Inc. | 1982-09-14 |
| K792083 | HAAG-STREIT SLIT LAMP 900 | Lumenis, Inc. | 1979-11-16 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00380650008404 | UNITY | Alcon Laboratories, Inc. | 2026-04-09 |
| 00380650008374 | UNITY | Alcon Laboratories, Inc. | 2026-04-09 |
| 00380650008381 | UNITY | Alcon Laboratories, Inc. | 2026-04-09 |
| 00380650008398 | UNITY | Alcon Laboratories, Inc. | 2026-04-09 |
| 07630802403711 | PROVEO 8x | Leica Microsystems (Schweiz) AG | 2025-10-03 |
| 04064434000193 | SeeLuma Digital Binoculars Module | Munich Surgical Imaging GmbH | 2025-08-05 |
| 17290115960591 | Microscope Cover MITAKA mm80, mm90, 80/266 | PHARMA SEPT MEDICAL PRODUCTS (1995) LTD. | 2025-06-11 |
| 27290115960598 | Microscope Cover MITAKA mm80, mm90, 80/266 | PHARMA SEPT MEDICAL PRODUCTS (1995) LTD. | 2025-06-11 |
| B366MC025 | PROCAM HD 2D | Ecleris | 2025-01-16 |
| 04064434000148 | SeeLuma Digital Binoculars Module | Munich Surgical Imaging GmbH | 2024-05-24 |
| 04064434000155 | SeeLuma Digital Binoculars Upgrade Kit | Munich Surgical Imaging GmbH | 2024-05-24 |
| 08908006463251 | Labomed Stella OPH microscope | LABOTECH MICROSCOPES INDIA PRIVATE LIMITED | 2023-06-15 |
| 08908006463268 | Labomed Stella OPH microscope with wall mount | LABOTECH MICROSCOPES INDIA PRIVATE LIMITED | 2023-06-15 |
| 08908006463312 | Labomed Prima OPH microscope (Basic, motorized fine focus) | LABOTECH MICROSCOPES INDIA PRIVATE LIMITED | 2023-06-15 |
| 08908006463329 | Labomed Prima OPH microscope (Motorized fine focus & X-Y coupling) | LABOTECH MICROSCOPES INDIA PRIVATE LIMITED | 2023-06-15 |
| 04064434000063 | SeeLuma Binoculars | Munich Surgical Imaging GmbH | 2023-04-03 |
| 04064434000056 | SeeLuma Re-Sterilizable Caps | Munich Surgical Imaging GmbH | 2023-04-03 |
| 00836230000011 | "Microscope Cover ZEISS ""MD"" 50/180 6.50" | PHARMA SEPT MEDICAL PRODUCTS (1995) LTD. | 2022-11-16 |
| 00836230000028 | "Microscope Cover ZEISS ""OPMI"" 115/180 4.85" | PHARMA SEPT MEDICAL PRODUCTS (1995) LTD. | 2022-11-16 |
| 00836230000035 | Microscope Cover LEICA 115/180 7.00 | PHARMA SEPT MEDICAL PRODUCTS (1995) LTD. | 2022-11-16 |
| 00836230000042 | "Microscope Cover ZEISS ""OPMI"" 50/180 4.85" | PHARMA SEPT MEDICAL PRODUCTS (1995) LTD. | 2022-11-16 |
| 00836230000059 | "Microscope Cover ZEISS ""OPMI"" 115/260 4.85" | PHARMA SEPT MEDICAL PRODUCTS (1995) LTD. | 2022-11-16 |
| 00836230000066 | Microscope Cover LEICA 115/260 7.00 | PHARMA SEPT MEDICAL PRODUCTS (1995) LTD. | 2022-11-16 |
| 00836230000073 | Microscope Cover LEICA 115/300 7.00 | PHARMA SEPT MEDICAL PRODUCTS (1995) LTD. | 2022-11-16 |
| 00836230000103 | "Microscope Cover ZEISS ""MD"" 115/180 6.50" | PHARMA SEPT MEDICAL PRODUCTS (1995) LTD. | 2022-11-16 |
| 00836230000127 | "Microscope Cover ZEISS ""MD"" 115/260 6.50" | PHARMA SEPT MEDICAL PRODUCTS (1995) LTD. | 2022-11-16 |
| 00836230000141 | Microscope Cover LEICA 115/180 7.0 HLT | PHARMA SEPT MEDICAL PRODUCTS (1995) LTD. | 2022-11-16 |
| 00836230000158 | Microscope Cover LEICA 50/180 7.00 | PHARMA SEPT MEDICAL PRODUCTS (1995) LTD. | 2022-11-16 |
| 00836230000189 | Microscope Cover LEICA 137/380 7.00 | PHARMA SEPT MEDICAL PRODUCTS (1995) LTD. | 2022-11-16 |
| 00836230000196 | Microscope Cover ZEISS 137/380 6.50 | PHARMA SEPT MEDICAL PRODUCTS (1995) LTD. | 2022-11-16 |