HMF · Stand, Instrument, Ac-Powered, Ophthalmic
Ophthalmic · 21 CFR 886.1860 · Class 1
Overview
| Product Code | HMF |
|---|---|
| Device Name | Stand, Instrument, Ac-Powered, Ophthalmic |
| Regulation | 21 CFR 886.1860 |
| Device Class | Class 1 |
| Review Panel | Ophthalmic |
Identification
An ophthalmic instrument stand is an AC-powered or nonpowered device intended to store ophthalmic instruments in a readily accessible position.
Classification Rationale
Class I (general controls). The AC-powered device and the battery-powered device are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9. The battery-powered device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Cleared Devices (15)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K935952 | ROTA SYSTEM 5000 | Rota Systems Medfurniture, Inc. | Apr 19, 1994 | SESE |
| K935945 | ROTA DATAMATE I | Rota Systems,Inc. | Apr 19, 1994 | SESE |
| K931839 | ROTA SYSTEM XL | Rota Systems Medfurniture, Inc. | Nov 22, 1993 | SESE |
| K930440 | MARCO INTERNATIONAL STAND | Marco Ophthalmic, Inc. | Jul 6, 1993 | SESE |
| K924780 | BURTON OPHTHALMIC EXAM UNIT - MODEL 2201 | R.H. Burton Co. | Apr 5, 1993 | SESE |
| K924771 | BURTON OPHTHALMIC STAND - MODEL XL3200 | R.H. Burton Co. | Apr 5, 1993 | SESE |
| K913961 | OPHTHALMIC STAND | Luneau Ophtalmologie SA | Dec 4, 1991 | SESE |
| K853358 | RELIANCE PENDULUM OPHTHALMIC DELIVERY SYSTEM | Dentsply Intl. | Oct 4, 1985 | SESE |
| K844362 | OPHTHALMIC CHAIR | Luneau Laboratories | Dec 11, 1984 | SESE |
| K844363 | OPHTHALMIC STAND | Luneau Laboratories | Dec 5, 1984 | SESE |
| K832073 | ELECTRIC INSTRUMENT TABLE | CooperVision, Inc. | Aug 12, 1983 | SESE |
| K812544 | RELIANCE OPHTHALMIC INSTRUMENT CONTROL | F. & F. Koenigkramer | Sep 21, 1981 | SESE |
| K803195 | SYSTEM 1 INSTRUMENT STAND | Surgical Mechanical Research, Inc. | Feb 4, 1981 | SESE |
| K791105 | B & L OPHTHALMIC CHAIR | Bausch & Lomb, Inc. | Jul 24, 1979 | SESE |
| K791104 | B & L OPHTHALMIC INSTRUMENT STAND | Bausch & Lomb, Inc. | Jul 24, 1979 | SESE |
Top Applicants
- Rota Systems Medfurniture, Inc. — 2 clearances
- R.H. Burton Co. — 2 clearances
- Luneau Laboratories — 2 clearances
- Bausch & Lomb, Inc. — 2 clearances
- Surgical Mechanical Research, Inc. — 1 clearance
