Optha Prep
FDA 510(k) K871706 · Treace Medical, Inc.
510(k) numberK871706
Submission
- Device name
- Optha Prep
- Applicant
- Treace Medical, Inc.
Memphis, TN, US - Received
- May 1, 1987
- Decision date
- May 18, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HMT – Drape, Patient, Ophthalmic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4370
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code HMT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K945738 | Visiflex Ophthalmic Surgical Incise DrapeHMT · Traditional | Visitec Co. | 02/14/1995SE |
| K905460 | Sterile Disposable Drape/Ophthalmic SurgeryHMT · Traditional | Angiosystems, Inc. | 02/06/1991SE |
| K872620 | Solos Eyesite DrapesHMT · Traditional | Solos Ophthalmology | 07/31/1987SE |
| K854613 | Surgical Drapes, OphthalminHMT · Traditional | Charles Atkins & Co. | 02/13/1986SE |
| K831340 | Drain-R-Drape(EyeHMT · Traditional | Sur-Tech, Inc. | 06/08/1983SE |
| K830822 | Eye DrapeHMT · Traditional | CooperVision, Inc. | 04/06/1983SE |
More from CooperVision, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K883727 | Bucket Prosthesis PorpETB · Traditional | 01/13/1989SE |
| K882349 | Mallet, SurgicalHXL · Traditional | 06/23/1988SE |
| K874779 | Bipolator 50GEI · Traditional | 01/29/1988SE |
| K873154 | Treace Magnum Oto-Tool SystemERL · Traditional | 09/04/1987SE |
| K872000 | Eye GardHOY · Traditional | 07/21/1987SE |
| K870765 | Cannulated Instrument CleanersEKW · Traditional | 05/27/1987SE |
| K870759 | Cleaning Solution, Catalog No. 8203LRJ · Traditional | 05/07/1987SE |
| K870766 | Prosthesis WireETB · Traditional | 04/15/1987SE |
| K870764 | Schuknecht Wire Cutting Scissors · Traditional | 03/18/1987SE |
| K870763 | Super Scissors · Traditional | 03/18/1987SE |
Questions and answers
When was Optha Prep cleared by the FDA?
Optha Prep (K871706) received a 510(k) decision of Substantially Equivalent on May 18, 1987, 17 days after the submission was received.
What is the product code of K871706?
The FDA product code is HMT – Drape, Patient, Ophthalmic, a Class II (moderate risk) device regulated under 21 CFR 878.4370.