Stand, Instrument, Ac-Powered, Ophthalmic
The AC-Powered Ophthalmic Instrument Stand is an electrically powered support stand used to hold and position ophthalmic diagnostic equipment such as slit lamps, refractors, and tonometers at the appropriate height and angle during patient examinations. It is classified as FDA Class 1, the lowest risk category, requiring only general controls without a premarket notification. The product code is HMF, regulated under 21 CFR 886.1860, within the Ophthalmic medical specialty. No special risk flags apply to this device.
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Basic Information
- Product Code
- HMF
- Device Class
- FDA class 1
- Regulation Number
- 886.1860
- Medical Specialty
- Ophthalmic
- Review Panel
- OP
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 15 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K935952 | ROTA SYSTEM 5000 | Apr 19, 1994 | Substantially Equivalent | Rota Systems Medfurniture, Inc. |
| K935945 | ROTA DATAMATE I | Apr 19, 1994 | Substantially Equivalent | Rota Systems,Inc. |
| K931839 | ROTA SYSTEM XL | Nov 22, 1993 | Substantially Equivalent | Rota Systems Medfurniture, Inc. |
| K930440 | MARCO INTERNATIONAL STAND | Jul 06, 1993 | Substantially Equivalent | Marco Ophthalmic, Inc. |
| K924780 | BURTON OPHTHALMIC EXAM UNIT - MODEL 2201 | Apr 05, 1993 | Substantially Equivalent | R.H. Burton Co. |
| K924771 | BURTON OPHTHALMIC STAND - MODEL XL3200 | Apr 05, 1993 | Substantially Equivalent | R.H. Burton Co. |
| K913961 | OPHTHALMIC STAND | Dec 04, 1991 | Substantially Equivalent | Luneau Ophtalmologie SA |
| K853358 | RELIANCE PENDULUM OPHTHALMIC DELIVERY SYSTEM | Oct 04, 1985 | Substantially Equivalent | Dentsply Intl. |
| K844362 | OPHTHALMIC CHAIR | Dec 11, 1984 | Substantially Equivalent | Luneau Laboratories |
| K844363 | OPHTHALMIC STAND | Dec 05, 1984 | Substantially Equivalent | Luneau Laboratories |
| K832073 | ELECTRIC INSTRUMENT TABLE | Aug 12, 1983 | Substantially Equivalent | CooperVision, Inc. |
| K812544 | RELIANCE OPHTHALMIC INSTRUMENT CONTROL | Sep 21, 1981 | Substantially Equivalent | F. & F. Koenigkramer |
| K803195 | SYSTEM 1 INSTRUMENT STAND | Feb 04, 1981 | Substantially Equivalent | Surgical Mechanical Research, Inc. |
| K791105 | B & L OPHTHALMIC CHAIR | Jul 24, 1979 | Substantially Equivalent | Bausch & Lomb, Inc. |
| K791104 | B & L OPHTHALMIC INSTRUMENT STAND | Jul 24, 1979 | Substantially Equivalent | Bausch & Lomb, Inc. |
FEI Numbers
This FDA classification entry is associated with 41 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 41 registration numbers. Click on an entry to view related FDA registrations.