Boston Eo (Enflufocon B) Contact Lens for Orthokeratolgy
FDA 510(k) K003932 · Polymer Technology
510(k) numberK003932
Submission
- Device name
- Boston Eo (Enflufocon B) 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
- HQD – Lens, Contact (Other Material) - Daily
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.5916
- Specialty
- Ophthalmic
Other 510(k)s with product code HQD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253822 | GPA (hexafocon A) Rigid Gas Permeable Contact LensesHQD · Traditional | Zhuhai Fitlens Medical Technology Co., Ltd. | 03/27/2026SE |
| K242393 | Acuity 181 (tisilfocon A) and Acuity 181 (tisilfocon A) with Tangible Hydra-PEG®…HQD · Traditional | Acuity Polymers, Inc. | 11/01/2024SE |
| K241398 | SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact LensesHQD · Traditional | Tianjin Mastervision Technology Co., Ltd. | 10/22/2024SE |
| K241571 | BostonSight® Specialty LensesHQD · Traditional | Boston Foundation For Sight, Inc. D/B/A… | 08/14/2024SE |
| K240618 | Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100 (hexafocon…HQD · Special | Acuity Polymers, Inc. | 04/03/2024SE |
| K233325 | Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A…HQD · Traditional | Visionary Optics, LLC | 02/21/2024SE |
| K230965 | Acuity 100 (hexafocon A) with Tangible Hydra-PEG®, TYRO-97 (hofocon A) with Tangible…HQD · Traditional | Acuity Polymers, Inc. | 06/16/2023SE |
| K230910 | NewVision SC (tisilfocon A) Scleral Lens; NewVision SC Daily Wear Ortho-K (tisilfocon A)…HQD · Traditional | Acculens, Inc. | 06/16/2023SE |
| K221768 | Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact LensesHQD · Traditional | Paragon Vision Sciences, Inc. | 05/05/2023SE |
| K223394 | Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A…HQD · Special | Visionary Optics, LLC | 12/07/2022SE |
More from Visionary Optics, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K011945 | Rigid Gas Permeable Contact Lens SolutionHQD · Traditional | 09/12/2001SE |
| K003933 | Boston Equalens II (Oprifocon a) Contact Lens for OrthokeratolgyMUW · 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 Eo (Enflufocon B) Contact Lens for Orthokeratolgy cleared by the FDA?
Boston Eo (Enflufocon B) Contact Lens for Orthokeratolgy (K003932) 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 K003932?
The FDA product code is HQD – Lens, Contact (Other Material) - Daily, a Class II (moderate risk) device regulated under 21 CFR 886.5916.