510(k) K051035

Device: SYNERGEYES (PAFLUCON D HEM-IBERFILCON A) HYBRID CONTACT LENS
Applicant: SYNERGEYES
510(k) number: K051035
Product code: HQD
Decision: Substantially Equivalent (SESE)
Decision date: 2005-09-02
Date received: 2005-04-22
Regulation: 886.5916
Classification name: Lens, Contact (other Material) - Daily
Medical specialty: Ophthalmic
Review panel: Ophthalmic
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

Contact: RICHARD E LIPPMAN
Address: 15825 Shady Grove Rd.Suite 30 Rockville MD US 20850 20850

FDA Registration Numbers#

3005147469
3001190611
3014964775
9612500
1000123221
1835957
3012228452
3003357577
3025308027
2030598
3014769028
3013398957
2031102
3032010300
3005994941
1313525
3005087645
3014175039
3022320387
3006204913
3033524682
3002830597
3022988037
9681630
1281950
3043365583
1720959
9614761
3003062331
1065845
3020246591
3010607087
1123818
3012719596

Source Documents#

Other 510(k) Records For Product Code HQD #

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

Legacy Summary#

summary

FDA Review#

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