GPA (hexafocon A) Rigid Gas Permeable Contact Lenses— 510(k) K253822
Substantially EquivalentZhuhai Fitlens Medical Technology Co., Ltd.
FDA 510(k) clearance K253822 for GPA (hexafocon A) Rigid Gas Permeable Contact Lenses, Substantially Equivalent on 2026-03-27. Applicant: Zhuhai Fitlens Medical Technology Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Zhuhai Fitlens Medical Technology Co., Ltd.
- 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
- Zhuhai, CN
Recent devices under product code HQD
view all- 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
- K233325 — Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A, fluoroxyfocon A)
Data sourced from openFDA. This site is unofficial and independent of the FDA.