Engine, Trephine, Accessories, Ac-Powered
An AC-Powered Trephine Engine with Accessories is a mains-powered ophthalmic surgical device used to drive a trephine cutting instrument for making controlled circular incisions in the cornea during corneal grafting or keratoplasty procedures, providing consistent rotational speed and cutting force. This device is FDA Class 1 (lowest risk), subject to general controls only without requiring premarket notification. It carries product code HRG and is regulated under 21 CFR 886.4070, within the Ophthalmic medical specialty.
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Basic Information
- Product Code
- HRG
- Device Class
- FDA class 1
- Regulation Number
- 886.4070
- Medical Specialty
- Ophthalmic
- Review Panel
- OP
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K013151 | ASMOTOM AUTOMATED TREPHINE SYSTEM | Dec 14, 2001 | Substantially Equivalent | Bkg Opthalmics USA, Inc. |
| K981063 | AUTOMATED CORNEAL TREPHINE | Jun 23, 1998 | Substantially Equivalent | Laser Center Dev. Corp. |
| K843957 | ULTRATHIN/SP LENS | Jul 31, 1985 | Substantially Equivalent | Optical Systems Intl., Inc. |
| K841515 | SCANLAN VASCU-STATT II | Jun 05, 1984 | Substantially Equivalent | Scanlan Intl., Inc. |
| K823901 | TREPHINE BLADES-VARIOUS MODELS | Jan 17, 1983 | Substantially Equivalent | Edward Weck, Inc. |
| K791763 | (MICRO-KERATRON, MICRO DUCT TREPHINE) | Nov 05, 1979 | Substantially Equivalent | Intl. Ophthalmic Industries Corp. |