Chrysalis Intelligence · Product Codes · HQD

HQD · Lens, Contact (Other Material) - Daily

Ophthalmic · 16 clearances · 9 unique sponsors

Device class
Class II
Regulation 886.5916
Total clearances
16
2020-09-08 → 2026-03-27
Last 12 months
1
Unique sponsors
9
Medical specialty
Ophthalmic
Review panel
OP
Regulation number
886.5916
Implant
N
Life-sustain / support
N
GMP exempt
N
Third-party review
Y
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Acuity Polymers, Inc. 6 0 2024-11-01
Valley Contax, Inc. 2 0 2022-01-07
Visionary Optics, LLC 2 0 2024-02-21
Acculens, Inc. 1 0 2023-06-16
Tianjin Mastervision Technology Co., Ltd. 1 0 2024-10-22
Boston Foundation For Sight, Inc. D/B/A Bostonsight 1 0 2024-08-14
Contamac, Ltd. 1 0 2022-03-17
Zhuhai Fitlens Medical Technology Co., Ltd. 1 1 2026-03-27
Paragon Vision Sciences, Inc. 1 0 2023-05-05
Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

CodeTypeDescriptionConfidenceRationale
V2500 HCPCS Contact lens, pmma, spherical, per lens ✓ CMS-verified description High Standard HCPCS code for contact lens, daily wear
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-03-27 K253822 Zhuhai Fitlens Medical Technology Co., Ltd. GPA (hexafocon A) Rigid Gas Permeable Contact Lenses
2024-11-01 K242393 Acuity Polymers, Inc. Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lenses
2024-10-22 K241398 Tianjin Mastervision Technology Co., Ltd. SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses
2024-08-14 K241571 Boston Foundation For Sight, Inc. D/B/A Bostonsight BostonSight® Specialty Lenses
2024-04-03 K240618 Acuity Polymers, Inc. Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100™ (hexafocon A) Rigid Gas Permeable Contact Lens; Acuity 200™ with Tangible® Hydra-PEG® (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100™ with Tangible® Hydra-PEG® (hexafocon A) Rigid Gas Permeable Contact Lens
2024-02-21 K233325 Visionary Optics, LLC Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A, fluoroxyfocon A)
2023-06-16 K230965 Acuity Polymers, Inc. Acuity 100™ (hexafocon A) with Tangible™ Hydra-PEG®, TYRO™-97 (hofocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lens
2023-06-16 K230910 Acculens, Inc. NewVision SC (tisilfocon A) Scleral Lens; NewVision SC Daily Wear Ortho-K (tisilfocon A) Corneo-Scleral Lens
2023-05-05 K221768 Paragon Vision Sciences, Inc. Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses
2022-12-07 K223394 Visionary Optics, LLC Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A)
2022-03-17 K212631 Contamac, Ltd. Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses
2022-01-07 K213880 Valley Contax, Inc. Custom Stable Rigid Gas Permeable Scleral Contact Lens
2021-12-30 K213538 Acuity Polymers, Inc. Acuity 200 with Tangible Hydra-PEG (fluoroxyfocon A) Rigid Gas Permeable Contact Lens
2021-05-11 K202860 Valley Contax, Inc. Valley Contax Single Vision (SV) Gas Permeable Contact Lens (roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enflufocon A), Valley Contax Goldeneye Aspheric Front Multifocal (AFM) Gas Permeable Contact Lens (roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enflufocon A), Valley Contax V Kone (VK) Gas Permeable Contact Lens (roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enflufocon A)
2021-04-09 K203571 Acuity Polymers, Inc. Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact Lens
2020-09-08 K201194 Acuity Polymers, Inc. Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens