HRJ · Table, Instrument, Powered, Ophthalmic
Ophthalmic · 21 CFR 886.4855 · Class 1
Overview
| Product Code | HRJ |
|---|---|
| Device Name | Table, Instrument, Powered, Ophthalmic |
| Regulation | 21 CFR 886.4855 |
| Device Class | Class 1 |
| Review Panel | Ophthalmic |
Identification
An ophthalmic instrument table is an AC-powered or manual device on which ophthalmic instruments are intended to be placed.
Classification Rationale
Class I (general controls). The AC-powered device and the manual 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 manual 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.
Recent Cleared Devices (7 of 7)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K930447 | MARCO H AND TS-1 INSTRUMENT TABLES | Marco Ophthalmic, Inc. | Jul 6, 1993 | SESE |
| K922242 | 910T MONTORIZED INSTRUMENT TABLE | R.H. Burton Co. | Sep 30, 1992 | SESE |
| K912134 | TBD, LENS MEASURING DEVICE | Alcon Laboratories | Jul 25, 1991 | SESE |
| K853744 | TECHNA VISION, INC.ELECTRIC TABLE | Techna Vision | Oct 17, 1985 | SESE |
| K853359 | RELIANCE 1379 | Dentsply Intl. | Sep 24, 1985 | SESE |
| K841760 | WOODLYN CLASSIC INSTRUMENT STAND | Woodlyn, Inc. | Jun 19, 1984 | SESE |
| K833820 | MACHEMER/TANO ROTATING | Optical Micro Systems, Inc. | Jan 4, 1984 | SESE |
Top Applicants
- Woodlyn, Inc. — 1 clearance
- Techna Vision — 1 clearance
- R.H. Burton Co. — 1 clearance
- Optical Micro Systems, Inc. — 1 clearance
- Marco Ophthalmic, Inc. — 1 clearance
