Automatic Lensometer
FDA 510(k) K936199 · Canon USA, Inc.
510(k) numberK936199
Submission
- Device name
- Automatic Lensometer
- Applicant
- Canon USA, Inc.
Lake Success, NY, US - Received
- December 29, 1993
- Decision date
- September 28, 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 |
| K940997 | AL-3300HLM · Traditional | Hoya Corp. USA | 09/29/1994SE |
| 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 |
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Questions and answers
When was Automatic Lensometer cleared by the FDA?
Automatic Lensometer (K936199) received a 510(k) decision of Substantially Equivalent on September 28, 1994, 273 days after the submission was received.
What is the product code of K936199?
The FDA product code is HLM – Instrument, Measuring, Lens, Ac-Powered, a Class I (low risk) device regulated under 21 CFR 886.1425.