Atlas FDA

BLUE 400

FDA 510(k) clearance K211346 · decided 2022-07-22

Clearance details

K-number
K211346
Device name
BLUE 400
Applicant
Carl Zeiss Meditec, AG
Decision
Substantially Equivalent
Date received
2021-05-03
Decision date
2022-07-22
Days to decision
445 days
Clearance type
Traditional
Product code
QFX
Device class
2
Regulation number
882.4950
Medical specialty
Neurology
Advisory committee
Neurology
Location
Jena, DE
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Affirm 400 (K251286)Digital Surgery Systems, Inc. (D.B.A True Digital Surgery)2026-01-21
BLUE 400; BLUE 400 S (K240215)Carl Zeiss Meditec, AG2024-06-28
Myriad SPECTRA Light Source (K232567)Nico Corporation2024-03-14
Leica FL400 (DEN180024)Leica Microsystems (Schweiz) AG2019-03-28

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
VISULAS 690 PLUS LASER & VISULINK PDT/U ADAPTER (P990048/S003)Carl Zeiss Meditec, AG2008-10-31
VISULAS 690S AND VISULINK PDT/U ADAPTER (P990048/S001)Carl Zeiss Meditec, AG2001-09-27
VISULAS 690S LASER AND VISULINK PDT ADAPTER (P990048/S002)Carl Zeiss Meditec, AG2001-07-03
ZEISS VISULAS 690 LASER AND VISULINK PDT ADAPTER (P990048)Carl Zeiss Meditec, AG2000-04-12
MENTOR POSTERIOR CHAMBER INTRAOCULAR UV ABSORBING PMMA LENSES (P830056/S079)Carl Zeiss Meditec, AG1999-05-11
POSTERIOR CHAMBER INTRAOCULAR LENSES (TIER A SUBMISSION) (P830056/S078)Carl Zeiss Meditec, AG1998-01-29
POSTERIOR CHAMBER INTROCULAR LENSES (P830056/S077)Carl Zeiss Meditec, AG1996-08-01
POSTERIOR CHAMBER INTROCULAR LENSES (P830056/S075)Carl Zeiss Meditec, AG1996-04-02