Unit, Cautery, Thermal, Ac-Powered
An AC-Powered Thermal Cautery Unit is an electrically powered ophthalmic surgical device that uses resistive heating of a probe tip to apply controlled thermal energy to ocular tissues for hemostasis, tissue ablation, or destruction of small lesions such as eyelid papillomas or corneal neovascularization. This device is FDA Class 2 (moderate risk), requiring premarket notification (510(k)) before marketing. It carries product code HQO and is regulated under 21 CFR 886.4115, within the Ophthalmic medical specialty. It is eligible for third-party review.
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Basic Information
- Product Code
- HQO
- Device Class
- FDA class 2
- Regulation Number
- 886.4115
- Medical Specialty
- Ophthalmic
- Review Panel
- OP
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 12 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K070871 | STARION UNIVERSAL POWER SUPPLY | Apr 13, 2007 | Substantially Equivalent | Starion Instruments |
| K043155 | STARION UNIVERSAL POWER SUPPLY (UPS) | Dec 09, 2004 | Substantially Equivalent | Starion Instruments |
| K002341 | THERMAL CAUTERY UNIT, MODEL 150 | Oct 23, 2000 | Substantially Equivalent | Geiger Medical Technologies, Inc. |
| K000893 | AC POWERED THERMAL CAUTERY UNIT | Jun 14, 2000 | Substantially Equivalent | Starion Instruments |
| K971538 | MENTOR GEMINI HEMOSTATIC ERASER | Jul 14, 1997 | Substantially Equivalent | Mentor Ophthalmics, Inc. |
| K962135 | D.O.R.C. MICRODIATHERMY SYSTEM | Aug 29, 1996 | Substantially Equivalent | Dutch Ophthalmic USA, Inc. |
| K943031 | BIPOLAR ELECTROSURGICAL PENCIL | Sep 23, 1994 | Substantially Equivalent | Boston Surgical Products, Inc. |
| K900913 | ADLER DISPOSABLE BIPOLAR CORD | Apr 04, 1990 | Substantially Equivalent | Adler Instrument Co. |
| K874367 | VARIOUS CARDIAC CRYOPROBES HAVING DIA. & COS. DIFF | Jan 04, 1988 | Substantially Equivalent | Spembly Medical , Ltd. |
| K852075 | SITE-MALIS BIPOLAR COAGULATOR MODULE | Aug 20, 1985 | Substantially Equivalent | Valley Forge Scientific Corp. |
| K844775 | EFFNER-EYE CAUTERY WITH BATTERY HANDLE | Aug 12, 1985 | Substantially Equivalent | Mecron Medical Products, Inc. |
| K810017 | MICROSURG CAUTERY | Jan 05, 1981 | Unknown | Medical Products Development, Inc. |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.