Veri-Vu Lensometer
FDA 510(k) K791521 · Intermedics, Inc.
510(k) numberK791521
Submission
- Device name
- Veri-Vu Lensometer
- Applicant
- Intermedics, Inc.
Mchenry, IL, US - Received
- August 10, 1979
- Decision date
- October 30, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HLM – Instrument, Measuring, Lens, Ac-Powered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.1425
- Specialty
- Ophthalmic
Other 510(k)s with product code HLM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K944022 | LenschekHLM · Traditional | Leica, Inc. | 11/17/1994SE |
| K940997 | AL-3300HLM · Traditional | Hoya Corp. USA | 09/29/1994SE |
| K936199 | Automatic LensometerHLM · Traditional | Canon USA, Inc. | 09/28/1994SE |
| K930441 | Marco Standard Lensmeters 101,201HLM · Traditional | Marco Ophthalmic, Inc. | 07/06/1993SE |
| K930445 | Marco LM-770 Digital Projection LensmeterHLM · Traditional | Marco Ophthalmic, Inc. | 06/21/1993SE |
| K924788 | Burton LensmeterHLM · Traditional | R.H. Burton Co. | 04/05/1993SE |
| K924785 | Burton Radiusgauge - Model 2030HLM · Traditional | R.H. Burton Co. | 04/05/1993SE |
| K924776 | Burton Lensmeter - Model 2021HLM · Traditional | R.H. Burton Co. | 04/05/1993SE |
| K920861 | Woodlyn Classic LensmeterHLM · Traditional | Woodlyn, Inc. | 07/30/1992SE |
| K884188 | Nidek LM-870 Automatic LensmeterHLM · Traditional | Nidek, Inc. | 11/23/1988SE |
More from Nidek, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K954610 | Model 430-07 Endocardial Pacing LeadDTB · Traditional | 12/16/1996PT |
| K955122 | Intermedics Model 436-07 Bipolar & Model 437-07 Unipolar Implantable Endocardial Pacing…DTB · Traditional | 11/04/1996ST |
| K962174 | Biplr Im En Pac Leads (430-07,432-03,436-02 & 07, 438-05 & 07)DTB · Traditional | 08/21/1996ST |
| K955550 | Cardifix Ez Bipolar/Unipolar Endocardial Pacing LeadDTB · Traditional | 06/19/1996ST |
| K960281 | Implantable Pacing Leads/Implantable Accessory/Non-Implantable AccessoryDTB · Traditional | 06/18/1996ST |
| K954719 | Intermedics Model 430-07 Bipolar Implantable Endocardial Pacing LeadDTB · Traditional | 02/27/1996ST |
| K933278 | Intermedics Triangle Chest Probe Model 526-04KRG · Traditional | 03/15/1995SE |
| K922042 | Cardifix Endocardial Pacing LeadDTB · Traditional | 04/29/1993SESP |
| K922972 | Models 438-05 and 435-05 Implantable Pacing LeadDTB · Traditional | 01/22/1993SESP |
| K920530 | Intermedics Model 366-15 VS 1 Header PlugDXY · Traditional | 03/17/1992SE |
Questions and answers
When was Veri-Vu Lensometer cleared by the FDA?
Veri-Vu Lensometer (K791521) received a 510(k) decision of Substantially Equivalent on October 30, 1979, 81 days after the submission was received.
What is the product code of K791521?
The FDA product code is HLM – Instrument, Measuring, Lens, Ac-Powered, a Class I (low risk) device regulated under 21 CFR 886.1425.