FLUOROPERM 151 (PAFLUFOCON D) AND PARAGON HDS 100 (PAFLUFOCON D) RIGID GAS PERMEABLE CONTACT LENSES— 510(k) K052983
Substantially EquivalentParagon Vision Sciences
FDA 510(k) clearance K052983 for FLUOROPERM 151 (PAFLUFOCON D) AND PARAGON HDS 100 (PAFLUFOCON D) RIGID GAS PERMEABLE CONTACT LENSES, Substantially Equivalent on 2006-02-10. Applicant: Paragon Vision Sciences. Device class: 2.
Clearance details
- Applicant
- Paragon Vision Sciences
- Product code
- Code HQD
- Device class
- Class 2
- Regulation
- 21 CFR 886.5916
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mesa, AZ, US
Recent devices under product code HQD
view all- K253822 — GPA (hexafocon A) Rigid Gas Permeable Contact Lenses
- K242393 — Acuity 181 (tisilfocon A) and Acuity 181 (tisilfocon A) with Tangible Hydra-PEG® Rigid Gas Permeable Contact Lenses
- K241398 — SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses
- K241571 — BostonSight® Specialty Lenses
- K240618 — Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact Lens +3 more
More clearances from Paragon Vision Sciences
view all- K180172 — FluoroPerm 30 & Paragon Thin (paflufocon C) RGP contact lenses with Tangible Hydra-PEG +3 more
- K120996 — FLUOROPERM 30 PARAGON HDS FLUOROPERM 60 PARAGON HDS 100 FLUOROPERM 92 FLUOROPERM 151 PARAGON THIN
- K082799 — HDS HI 1.54
- K070637 — FLUOROPERM 92, 60, 30 AND 151 AND PARAGON HDS, HDS 100 AND THIN RIGID GAS PERMEABLE CONTACT LENSES
- K013310 — PVS BASIC 2; EPIC 2
Data sourced from openFDA. This site is unofficial and independent of the FDA.