Automated Corneal Trephine
FDA 510(k) K981063 · Laser Center Dev. Corp.
510(k) numberK981063
Submission
- Device name
- Automated Corneal Trephine
- Applicant
- Laser Center Dev. Corp.
St. Louis, MO, US - Received
- March 23, 1998
- Decision date
- June 23, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HRG – Engine, Trephine, Accessories, Ac-Powered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.4070
- Specialty
- Ophthalmic
Other 510(k)s with product code HRG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K013151 | Asmotom Automated Trephine SystemHRG · Traditional | Bkg Opthalmics USA, Inc. | 12/14/2001SE |
| K843957 | Ultrathin/Sp LensHRG · Traditional | Optical Systems Intl., Inc. | 07/31/1985SE |
| K841515 | Scanlan Vascu-Statt IIHRG · Traditional | Scanlan Intl., Inc. | 06/05/1984SE |
| K823901 | Trephine Blades-Various ModelsHRG · Traditional | Edward Weck, Inc. | 01/17/1983SE |
| K791763 | (Micro-Keratron, Micro Duct Trephine)HRG · Traditional | Intl. Ophthalmic Industries Corp. | 11/05/1979SE |
More from Intl. Ophthalmic Industries Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K981235 | OculostatHNC · Traditional | 07/15/1998SE |
Questions and answers
When was Automated Corneal Trephine cleared by the FDA?
Automated Corneal Trephine (K981063) received a 510(k) decision of Substantially Equivalent on June 23, 1998, 92 days after the submission was received.
What is the product code of K981063?
The FDA product code is HRG – Engine, Trephine, Accessories, Ac-Powered, a Class I (low risk) device regulated under 21 CFR 886.4070.