AL-3300
FDA 510(k) K940997 · Hoya Corp. USA
510(k) numberK940997
Submission
- Device name
- AL-3300
- Applicant
- Hoya Corp. USA
Lake Success, NY, US - Received
- March 4, 1994
- Decision date
- September 29, 1994
- 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 |
| 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 |
| K862518 | Bausch & Lomb Vertometer V-5HLM · Traditional | Bausch & Lomb, Inc. | 08/11/1986SE |
Questions and answers
When was AL-3300 cleared by the FDA?
AL-3300 (K940997) received a 510(k) decision of Substantially Equivalent on September 29, 1994, 209 days after the submission was received.
What is the product code of K940997?
The FDA product code is HLM – Instrument, Measuring, Lens, Ac-Powered, a Class I (low risk) device regulated under 21 CFR 886.1425.