Boston Equalens II (Oprifocon a) Contact Lens for Orthokeratolgy
FDA 510(k) K003933 · Polymer Technology
510(k) numberK003933
Submission
- Device name
- Boston Equalens II (Oprifocon a) Contact Lens for Orthokeratolgy
- Applicant
- Polymer Technology
Rochester, NY, US - Received
- December 20, 2000
- Decision date
- February 16, 2001
- Decision
- Substantially Equivalent (SESE)
- 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 |
| K000224 | Fluroperm 60-OK, Paragon Hds-OkMUW · Traditional | Paragon Vision Sciences | 04/17/2000SESU |
| 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 |
|---|---|---|
| K011945 | Rigid Gas Permeable Contact Lens SolutionHQD · Traditional | 09/12/2001SE |
| K003932 | Boston Eo (Enflufocon B) Contact Lens for OrthokeratolgyHQD · Traditional | 02/16/2001SE |
| K002025 | Rigid Gas Permeable Contact LensHQD · Traditional | 10/31/2000SE |
| K001960 | Rigid Gas Permeable Contact LensHQD · Traditional | 08/28/2000SE |
| K000795 | Rigid Gas Permeable Contact LensHQD · Traditional | 05/26/2000SE |
| K980133 | Bausch & Lomb Wetting and Soaking SolutionLPN · Traditional | 03/11/1998SE |
| K974466 | Boston Advance CleanerMRC · Traditional | 02/19/1998SE |
| K973217 | Boston Liquid Enzymatic CleanerLPN · Traditional | 11/24/1997SE |
| K970698 | Boston Es Multivision (Enflufocon a) Contact LensHQD · Traditional | 05/06/1997SE |
| K951552 | Boston Contact Lens CaseLRX · Traditional | 06/26/1995SE |
Questions and answers
When was Boston Equalens II (Oprifocon a) Contact Lens for Orthokeratolgy cleared by the FDA?
Boston Equalens II (Oprifocon a) Contact Lens for Orthokeratolgy (K003933) received a 510(k) decision of Substantially Equivalent on February 16, 2001, 58 days after the submission was received.
What is the product code of K003933?
The FDA product code is MUW – Lens, Contact (Orthokeratology), a Class II (moderate risk) device regulated under 21 CFR 886.5916.