TBD, Lens Measuring Device
FDA 510(k) K912134 · Alcon Laboratories
510(k) numberK912134
Submission
- Device name
- TBD, Lens Measuring Device
- Applicant
- Alcon Laboratories
Fort Worth, TX, US - Received
- May 14, 1991
- Decision date
- July 25, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HRJ – Table, Instrument, Powered, Ophthalmic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.4855
- Specialty
- Ophthalmic
Other 510(k)s with product code HRJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K930447 | Marco H and TS-1 Instrument TablesHRJ · Traditional | Marco Ophthalmic, Inc. | 07/06/1993SE |
| K922242 | 910T Montorized Instrument TableHRJ · Traditional | R.H. Burton Co. | 09/30/1992SE |
| K853744 | Techna Vision, Inc.Electric TableHRJ · Traditional | Techna Vision | 10/17/1985SE |
| K853359 | Reliance 1379HRJ · Traditional | Dentsply Intl. | 09/24/1985SE |
| K841760 | Woodlyn Classic Instrument StandHRJ · Traditional | Woodlyn, Inc. | 06/19/1984SE |
| K833820 | Machemer/Tano RotatingHRJ · Traditional | Optical Micro Systems, Inc. | 01/04/1984SE |
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| K233856 | Precision1; Precision1 for Astigmatism; TOTAL30; TOTAL30 for Astigmatism; TOTAL30…LPL · Special | 12/29/2023SE |
| K232921 | DAILIES TOTAL1®; DAILIES TOTAL1® Toric; DAILIES TOTAL1® Multifocal; DAILIES TOTAL1®…LPL · Traditional | 11/16/2023SE |
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Questions and answers
When was TBD, Lens Measuring Device cleared by the FDA?
TBD, Lens Measuring Device (K912134) received a 510(k) decision of Substantially Equivalent on July 25, 1991, 72 days after the submission was received.
What is the product code of K912134?
The FDA product code is HRJ – Table, Instrument, Powered, Ophthalmic, a Class I (low risk) device regulated under 21 CFR 886.4855.