Chiroflex II Lens Microsert(Tm)
FDA 510(k) K914311 · Chiron Ophthalmics
510(k) numberK914311
Submission
- Device name
- Chiroflex II Lens Microsert(Tm)
- Applicant
- Chiron Ophthalmics
Irvine, CA, US - Received
- September 26, 1991
- Decision date
- January 27, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HQL – Intraocular Lens
- Device class
- Class III (high risk)
- Regulation
- 21 CFR 886.3600
- Specialty
- Ophthalmic
- Implant
- Yes
Other 510(k)s with product code HQL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K913626 | Softrans InjectorHQL · Traditional | Staar Surgical Co. | 12/18/1991SE |
| K842892 | Nidek Digital KeratometerHQL · Traditional | Nidek, Inc. | 10/05/1984SE |
| K842504 | Amer. Medical Optics Digital Kerato-HQL · Traditional | American Medical Optics | 10/01/1984SE |
| K771933 | Cilco Anterior Chamber LensHQL · Traditional | California Intraocular Lens | 01/26/1978SE |
More from California Intraocular Lens
| 510(k) | Device | Decision |
|---|---|---|
| K915861 | Medilens-Cs Corneal ShieldMOE · Traditional | 03/06/1992SE |
| K905825 | Collagen Shield, Various ModelsMOE · Traditional | 06/10/1991SE |
| K903575 | Chiroflex ForcepsKYB · Traditional | 12/21/1990SE |
| K903574 | Chiroflex Lens MicrosertKYB · Traditional | 09/17/1990SE |
| K901880 | Medilens(Tm) Corneal ShieldMOE · Traditional | 07/02/1990SE |
| K894162 | OptisolLYX · Traditional | 01/12/1990SE |
| K885015 | Coi 72 HR Collagen ShieldMOE · Traditional | 06/23/1989SE |
| K885016 | Coi 24 HR Collagen ShieldMOE · Traditional | 02/01/1989SE |
| K882762 | Collagen ShieldMOE · Traditional | 09/12/1988SE |
Questions and answers
When was Chiroflex II Lens Microsert(Tm) cleared by the FDA?
Chiroflex II Lens Microsert(Tm) (K914311) received a 510(k) decision of Substantially Equivalent on January 27, 1992, 123 days after the submission was received.
What is the product code of K914311?
The FDA product code is HQL – Intraocular Lens, a Class III (high risk) device regulated under 21 CFR 886.3600.