Fluroperm 60-OK, Paragon Hds-Ok
FDA 510(k) K000224 · Paragon Vision Sciences
510(k) numberK000224
Submission
- Device name
- Fluroperm 60-OK, Paragon Hds-Ok
- Applicant
- Paragon Vision Sciences
Mesa, AZ, US - Received
- January 24, 2000
- Decision date
- April 17, 2000
- Decision
- Unknown (SESU)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MUW – Lens, Contact (Orthokeratology)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.5916
- Specialty
- Ophthalmic
Other 510(k)s with product code MUW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K183200 | iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact LensesMUW · Traditional | C&E GP Specialist, Inc. | 01/09/2019SE |
| K160859 | OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E)MUW · Traditional | Contamac, Ltd. | 07/13/2016SE |
| K010109 | Fluoroperm 151-OK, Paragon HDS 100-OKMUW · Traditional | Paragon Vision Sciences | 02/28/2001SESU |
| K003933 | Boston Equalens II (Oprifocon a) Contact Lens for OrthokeratolgyMUW · Traditional | Polymer Technology | 02/16/2001SE |
| K973697 | Airperm (Siflufocon a) Rigid Gas Permeable Ok Contact Lenses for Daily Wear…MUW · Traditional | Airperm, Inc. | 04/08/1998SE |
More from Airperm, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K221768 | Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact LensesHQD · Traditional | 05/05/2023SE |
| K180172 | FluoroPerm 30 & Paragon Thin (paflufocon C) RGP contact lenses with Tangible Hydra-PEG…HQD · Traditional | 03/16/2018SE |
| K120996 | Fluoroperm 30 Paragon HDS Fluoroperm 60 Paragon HDS 100 Fluoroperm 92 Fluoroperm 151…HQD · Traditional | 06/28/2012SE |
| K082799 | HDS Hi 1.54HQD · Traditional | 01/27/2009SE |
| K070637 | Fluoroperm 92, 60, 30 and 151 and Paragon HDS, HDS 100 and Thin Rigid Gas Permeable…HQD · Traditional | 05/01/2007SE |
| K052983 | Fluoroperm 151 (Paflufocon D) and Paragon HDS 100 (Paflufocon D) Rigid Gas Permeable…HQD · Traditional | 02/10/2006SE |
| K013310 | PVS Basic 2; Epic 2HQD · Traditional | 04/25/2002SE |
| K010109 | Fluoroperm 151-OK, Paragon HDS 100-OKMUW · Traditional | 02/28/2001SESU |
| K002845 | Paflufocon C and E Daily Contact LensHQD · Traditional | 12/08/2000SE |
| K993586 | Sportsight GPHQD · Traditional | 05/22/2000SE |
Questions and answers
When was Fluroperm 60-OK, Paragon Hds-Ok cleared by the FDA?
Fluroperm 60-OK, Paragon Hds-Ok (K000224) received a 510(k) decision of Unknown on April 17, 2000, 84 days after the submission was received.
What is the product code of K000224?
The FDA product code is MUW – Lens, Contact (Orthokeratology), a Class II (moderate risk) device regulated under 21 CFR 886.5916.