Surgical Eye Shield
FDA 510(k) K781960 · Concept, Inc.
510(k) numberK781960
Submission
- Device name
- Surgical Eye Shield
- Applicant
- Concept, Inc.
Mchenry, IL, US - Received
- November 21, 1978
- Decision date
- February 9, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HJK – Lens, Contact, Polymethylmethacrylate, Diagnostic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.1385
- Specialty
- Ophthalmic
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|---|---|---|---|
| K201909 | RxSight Contact LensHJK · Traditional | Rxsight, Inc. | 09/10/2020SE |
| K173944 | Endocular Viewing Lenses and Silicone RingHJK · Traditional | Phakos | 10/25/2018SE |
| K151961 | Volk Disposable Iridotomy Lens, Volk Disposable Capsulotomy LensHJK · Special | Volk Optical, Inc. | 08/18/2015SE |
| K142715 | Sensor Medical Family of Vitrectomy Lenses and ProductsHJK · Traditional | Sensor Medical Technology, LLC | 12/16/2014SE |
| K051630 | Super View Disposable Biom Lens SetHJK · Traditional | Insight Instruments, Inc. | 06/29/2005SE |
| K051103 | Haag-Streit Contact Glasses Stery Cup, AccessoryHJK · Traditional | Haag-Streit USA, Inc. | 06/07/2005SE |
| K050623 | Volk Disposable Vitrectomy Lenses, Models Volk Flat SSV D, Volk Afx SSV D, Volk 45 Prism…HJK · Special | Volk Optical, Inc. | 03/28/2005SE |
| K033950 | Dorc Vitrectomy Lenses, Model 1284 SeriesHJK · Traditional | Dutch Ophthalmic Research Center (D.O.R.C.) | 02/20/2004SE |
| K030054 | Disposable Vitrectomy Sets, Disposable Virectomy LensesHJK · Traditional | Fci Ophthalmics, Inc. | 02/26/2003SE |
| K023221 | Contact Laser & Diagnostic LensesHJK · Special | Volk Optical, Inc. | 10/11/2002SE |
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| K896648 | Concept Unicompartmental Knee SystemHSX · Traditional | 06/05/1990SN |
| K894929 | Staple Fixation SystemJDR · Traditional | 08/30/1989SE |
| K892376 | Intravision(Tm) Arthroscope System (Add'L Appli.)HRX · Traditional | 08/01/1989SE |
| K891109 | Panda(R) Needle Catheter Jejunostomy TubeKNT · Traditional | 05/08/1989SE |
| K881954 | Concept Power SystemHSZ · Traditional | 11/09/1988SE |
| K884255 | Concept CCT-5200, Thermal Therapy SystemILO · Traditional | 11/08/1988SE |
| K882121 | C-Flo Suction TubeDXQ · Traditional | 06/20/1988SE |
| K880414 | Tendon HarvesterHRX · Traditional | 03/25/1988SE |
Questions and answers
When was Surgical Eye Shield cleared by the FDA?
Surgical Eye Shield (K781960) received a 510(k) decision of Substantially Equivalent on February 9, 1979, 80 days after the submission was received.
What is the product code of K781960?
The FDA product code is HJK – Lens, Contact, Polymethylmethacrylate, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 886.1385.