AT 030
FDA 510(k) clearance K180839 · decided 2018-06-07
Clearance details
- K-number
- K180839
- Device name
- AT 030
- Applicant
- Carl Zeiss Meditec, AG
- Decision
- Substantially Equivalent
- Date received
- 2018-03-30
- Decision date
- 2018-06-07
- Days to decision
- 69 days
- Clearance type
- Traditional
- Product code
- HKY
- Device class
- 2
- Regulation number
- 886.1930
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Jena, DE
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Carl Zeiss Meditec
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| iCare ST500 (TA04) (K241447) | Icare Finland OY | 2024-09-27 |
| Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes (16305, 16306, 16318) (K233516) | Reichert, Inc. | 2024-05-01 |
| CATS-L Tonometer™ Prism (K234037) | Cats Tonometer, LLC | 2024-02-09 |
| Applanation Tonometer HT-5000 (K232143) | Huvitz Co., Ltd. | 2023-10-23 |
| iCare IC200 (K220852) | Icare Finland OY | 2022-10-06 |
| iCare HOME2 (K211355) | Icare Finland OY | 2022-01-25 |
| CATS®-D Tonometer Prism (K203850) | Cats Tonometer, LLC | 2021-06-14 |
| Icare HOME Tonometer (K200966) | Icare Finland OY | 2020-05-07 |
| Icare ic200 (K190316) | Icare Finland OY | 2020-01-14 |
| Sunkingdom Applanation Tonometer SK-R, SK-T, SK-Q (K191314) | Chongqing Sunkingdom Medical Instrument Co., Ltd. | 2019-12-19 |
| Applanation tonometer AT-2 (K182491) | Takagi Seiko Co., Ltd. | 2018-12-10 |
| CATS Tonometer Prism (K173904) | Cats Tonometer, LLC | 2018-03-09 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| VISULAS 690 PLUS LASER & VISULINK PDT/U ADAPTER (P990048/S003) | Carl Zeiss Meditec, AG | 2008-10-31 |
| VISULAS 690S AND VISULINK PDT/U ADAPTER (P990048/S001) | Carl Zeiss Meditec, AG | 2001-09-27 |
| VISULAS 690S LASER AND VISULINK PDT ADAPTER (P990048/S002) | Carl Zeiss Meditec, AG | 2001-07-03 |
| ZEISS VISULAS 690 LASER AND VISULINK PDT ADAPTER (P990048) | Carl Zeiss Meditec, AG | 2000-04-12 |
| MENTOR POSTERIOR CHAMBER INTRAOCULAR UV ABSORBING PMMA LENSES (P830056/S079) | Carl Zeiss Meditec, AG | 1999-05-11 |
| POSTERIOR CHAMBER INTRAOCULAR LENSES (TIER A SUBMISSION) (P830056/S078) | Carl Zeiss Meditec, AG | 1998-01-29 |
| POSTERIOR CHAMBER INTROCULAR LENSES (P830056/S077) | Carl Zeiss Meditec, AG | 1996-08-01 |
| POSTERIOR CHAMBER INTROCULAR LENSES (P830056/S075) | Carl Zeiss Meditec, AG | 1996-04-02 |