Marco Standard Lensmeters 101,201
FDA 510(k) K930441 · Marco Ophthalmic, Inc.
510(k) numberK930441
Submission
- Device name
- Marco Standard Lensmeters 101,201
- Applicant
- Marco Ophthalmic, Inc.
Jacksonville, FL, US - Received
- January 26, 1993
- Decision date
- July 6, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
| 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 |
| K862518 | Bausch & Lomb Vertometer V-5HLM · Traditional | Bausch & Lomb, Inc. | 08/11/1986SE |
More from Bausch & Lomb, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K943234 | MS-30 Automatic PerimeterHPT · Traditional | 07/27/1994SE |
| K930444 | Marco Standard KeratometersHJB · Traditional | 08/09/1993SE |
| K930442 | Marco GXX Series Photographic Slit LampsHKI · Traditional | 08/09/1993SE |
| K930438 | Marco Models G,H and Primary Care Slit LampsHJO · Traditional | 08/09/1993SE |
| K930437 | Marco Standard RadiusgaugesHLF · Traditional | 08/09/1993SE |
| K930439 | Marco Surgiscope Operation MicroscopesHRM · Traditional | 07/22/1993SE |
| K930449 | Marco, Marcotilt, Encore and Custom ChairHME · Traditional | 07/06/1993SE |
| K930447 | Marco H and TS-1 Instrument TablesHRJ · Traditional | 07/06/1993SE |
| K930446 | Marco Trial SetsHPC · Traditional | 07/06/1993SE |
| K930443 | Marco CP-600 Auto Chart PROJECTOR/CP-1 Chart ProjeHOS · Traditional | 07/06/1993SE |
Questions and answers
When was Marco Standard Lensmeters 101,201 cleared by the FDA?
Marco Standard Lensmeters 101,201 (K930441) received a 510(k) decision of Substantially Equivalent on July 6, 1993, 161 days after the submission was received.
What is the product code of K930441?
The FDA product code is HLM – Instrument, Measuring, Lens, Ac-Powered, a Class I (low risk) device regulated under 21 CFR 886.1425.