510(k) K230910

Device: NewVision SC (tisilfocon A) Scleral Lens; NewVision SC Daily Wear Ortho-K (tisilfocon A) Corneo-Scleral Lens
Applicant: Acculens, Inc.
510(k) number: K230910
Product code: HQD
Decision: Substantially Equivalent (SESE)
Decision date: 2023-06-16
Date received: 2023-03-31
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

Related Records

Applicant Contact

Contact: Troy Miller
Address: 5353 W. Colfax Ave. Lakewood CO US 80214 80214

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

510(k) summary PDF

Other 510(k) Records For Product Code HQD

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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
K201194	Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact Lens	Acuity Polymers, Inc.	2020-09-08