Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
Ophthalmic — Predicate Candidate Screening
4,750 FDA 510(k) clearances under this medical specialty; the 50 most recent screened below.
100 daysmedian FDA review time
268 days90th percentile
2,000clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261312 | Temporary Keratoprosthesis (QuickSet TKP™) | Eyekon Medical, Inc. | 2026-07-24 | 94 | 0 |
| K261812 | HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact L | HOYA Lamphun , Ltd. | 2026-07-07 | 36 | 0 |
| K253704 | iPredict-DR | iHealthscreen, Inc. | 2026-07-02 | 220 | 0 |
| K253176 | TearView | Beyond 700 Pty, Ltd. | 2026-06-22 | 269 | 0 |
| K261174 | RxSight® Insertion Device | Rxsight, Inc. | 2026-06-10 | 62 | 0 |
| K260507 | Interojo 45 (inofilcon A) Soft (Hydrophilic) Silicone Hydrog | INTEROJO, Inc. | 2026-05-29 | 101 | 0 |
| K253352 | Pegavision (Polymacon) Daily Disposable Soft (Hydrophilic) C | Pegavision Corporation | 2026-05-21 | 233 | 0 |
| K261299 | Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) | Pegavision Corporation | 2026-05-19 | 29 | 0 |
| K261264 | Stellaris Elite™ vision enhancement system; Posterior and Co | Bausch and Lomb | 2026-05-15 | 29 | 0 |
| K253837 | SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex Module | Heidelberg Engineering GmbH | 2026-05-07 | 157 | 0 |
| K252455 | FSYX Ocular Pressure Adjusting Pump | Balance Ophthalmics, Inc. | 2026-04-30 | 268 | 0 |
| K253885 | PUSCON WATER BALANCE-1DAY TINT (omafilcon A) SOFT (HYDROPHIL | GEO MEDICAL CO., LTD. | 2026-04-29 | 146 | 0 |
| K252409 | TearCare MGX System | Sight Sciences, Inc. | 2026-04-27 | 269 | 0 |
| K252979 | Voyager DSLT (430840610) | Belkin Vision, Ltd. | 2026-04-07 | 202 | 0 |
| K253586 | RM Electrode (RMH 25-01) | Retmap, Inc. | 2026-04-01 | 135 | 0 |
| K253822 | GPA (hexafocon A) Rigid Gas Permeable Contact Lenses | Zhuhai Fitlens Medical Technology Co., Ltd. | 2026-03-27 | 119 | 0 |
| K252052 | Stellaris Elite™ vision enhancement system (BL11145, BL14455 | Bausch and Lomb, Incorporated | 2026-03-25 | 267 | 0 |
| K254269 | Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft | St. shine Optical Co., Ltd. | 2026-03-19 | 79 | 0 |
| K253834 | VISUREF 600 | Carl Zeiss Vision GmbH | 2026-03-18 | 107 | 0 |
| K252385 | Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) | Pegavision Corporation | 2026-03-13 | 225 | 0 |
| K251848 | Pentacam® Cornea OCT | Oculus Optikgeräte GmbH | 2026-03-13 | 270 | 0 |
| K254052 | DAILIES TOTAL1®; DAILIES TOTAL1® Multifocal | Alcon Laboratories, Inc. | 2026-02-13 | 58 | 0 |
| K252175 | LANDR Contact LENS Case | Fourth Axis, LLC | 2026-02-10 | 214 | 0 |
| K251507 | INTEGRE LIO | Quantel Medical | 2026-02-06 | 266 | 0 |
| K251353 | Eyer 2 | Phelcom Technologies | 2026-01-16 | 261 | 0 |
| K252633 | UNITY DX (UDX) | Cylite Pty. , Ltd. | 2025-12-23 | 125 | 0 |
| K251683 | Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Con | Bruno Vision Care, LLC | 2025-12-23 | 207 | 0 |
| K252348 | Tomey Optical Biometer OA-2000 (OA-2000) | Tomey Corporation | 2025-12-18 | 142 | 0 |
| K252120 | Fundus On Phone Non Mydriatic (FOP NM-10) | Remidio Innovative Solutions Private Limited | 2025-12-12 | 158 | 0 |
| K250501 | System Sophi | This AG | 2025-11-14 | 267 | 0 |
| K253039 | AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA | Topcon Corporation | 2025-11-07 | 46 | 0 |
| K251772 | Navilas Laser System 577sl (156691) | Od-Os GmbH | 2025-10-29 | 141 | 0 |
| K251876 | cleadew GP hydra one | Ophtecs Corporation | 2025-10-09 | 113 | 0 |
| K250364 | Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft | St. shine Optical Co., Ltd. | 2025-10-07 | 239 | 0 |
| DEN250016 | Essilor® Stellest® | Essilor Of America, Inc. | 2025-09-25 | 150 | 0 |
| K244009 | Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophil | Yung Sheng Optical Co., Ltd. | 2025-09-25 | 273 | 0 |
| K252682 | LenSx Laser System (8065000944) | Alcon Laboratories, Inc. | 2025-09-24 | 30 | 0 |
| K251095 | Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Len | Pegavision Corporation | 2025-09-17 | 160 | 0 |
| K252540 | ACCUJECT Injector Set 2.1-1P (LP604590) | Medicel AG | 2025-09-16 | 35 | 0 |
| K251573 | VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophil | Vizionfocus, Inc. | 2025-09-10 | 111 | 0 |
| K250770 | Optina-4C (MHRC-C1N) | Optina Diagnostics, Inc. | 2025-09-04 | 175 | 0 |
| K243600 | 3nethra neo HD FA; 3nethra neo HD | Forus Health Pvt.Ltd | 2025-08-14 | 266 | 0 |
| K243395 | MICOR 700 with Auto I/A | Carl Zeiss Meditec Cataract Technology, Inc. | 2025-08-08 | 281 | 0 |
| K250495 | MINI VP1 (PL67_F); MINI VP1 (PL61_F) | Avizor S.A. | 2025-08-01 | 162 | 0 |
| K242855 | P-CON (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, | E.O.S Co., Ltd. | 2025-07-30 | 313 | 0 |
| K250553 | Tomey Cornea/Anterior Segment OCT (CASIA2) | Tomey Corporation | 2025-07-18 | 143 | 0 |
| K243868 | Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) | Pegavision Corporation | 2025-07-02 | 197 | 0 |
| K250143 | Digital Prism Correction Feature (DPCF) | Apple, Inc. | 2025-06-23 | 157 | 0 |
| K243014 | EyeQ nanoECP | Eyeq, Inc. | 2025-06-18 | 264 | 0 |
| K242801 | MICOR 700 System (N/A); MICOR 700 drive (FG-50631); MICOR 70 | Carl Zeiss Meditec Cataract Technology, Inc. | 2025-06-11 | 267 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda