The Ocuplot D
FDA 510(k) K822415 · Coherent Medical Division
510(k) numberK822415
Submission
- Device name
- The Ocuplot D
- Applicant
- Coherent Medical Division
Mchenry, IL, US - Received
- August 11, 1982
- Decision date
- September 7, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HPJ – Instrument, Visual Field, Laser
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.1360
- Specialty
- Ophthalmic
Other 510(k)s with product code HPJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K864012 | Iras PerimeterHPJ · Traditional | Randwal Instrument Co., Inc. | 12/12/1986SE |
| K853556 | Laser IrasHPJ · Traditional | Randwal Instrument Co., Inc. | 11/01/1985SE |
| K813429 | Laser Photocoagulator Argon Med. LaserHPJ · Traditional | American Laser Corp. | 01/22/1982SE |
| K781507 | RetinometerHPJ · Traditional | Coburn Optical Ind., Inc. | 11/15/1978SE |
More from Coburn Optical Ind., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K902990 | Coherent Holmium:Yag Surgical LaserGEX · Traditional | 10/02/1990SE |
| K822908 | Coherent Fundusl Retinal CameraHKI · Traditional | 01/05/1983SE |
| K801906 | Dioptron III AutorefractorHKO · Traditional | 08/27/1980SE |
| K801336 | Model 900K PhotocoagulatorHQF · Traditional | 07/28/1980SE |
| K791895 | Accessories for Sys. 400 CO2 Surg. LaserGEX · Traditional | 12/20/1979SE |
Questions and answers
When was The Ocuplot D cleared by the FDA?
The Ocuplot D (K822415) received a 510(k) decision of Substantially Equivalent on September 7, 1982, 27 days after the submission was received.
What is the product code of K822415?
The FDA product code is HPJ – Instrument, Visual Field, Laser, a Class II (moderate risk) device regulated under 21 CFR 886.1360.