Atlas FDA

ARGON/KRYPTON & KRYPTON LASER PHOTOCOAGULATION SYS

FDA 510(k) clearance K844197 · decided 1984-12-24

Clearance details

K-number
K844197
Device name
ARGON/KRYPTON & KRYPTON LASER PHOTOCOAGULATION SYS
Applicant
Nidek, Inc.
Decision
Substantially Equivalent
Date received
1984-10-30
Decision date
1984-12-24
Days to decision
55 days
Clearance type
Traditional
Product code
HQB
Device class
2
Regulation number
886.4690
Medical specialty
Ophthalmic
Advisory committee
Ophthalmic
Location
Palo Alto, CA, US
Third-party review
No
Expedited review
No

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PEREGRINE 23GA CURVED LASER PROBE (K122905)Peregrine Surgical , Ltd.2013-04-30
SYNERGETICS DIRECTIONAL ENDOOCULAR LASER PROBE (K113857)Synergetics, Inc.2012-04-23
27+ ULTRAVIT PROBE, 27+ FLEX-TIP LASER PROBE, 27+ ENDOILLUMINATOR PROBE, 27+ VALVED ENTRY SYSTEM, 27+ INFUSION CANNULA (K110951)Alcon Research, Ltd.2011-10-17
NIDEK MULTICOLOR SCAN LASER PHOTOCOAGULATOR MC-500 VIXI (K111493)Nidek Co., Ltd.2011-07-27
NIDEK MULTICOLOR LASER PHOTOCOAGULATOR (K110228)Nidek Incorporated2011-02-23
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GAMP & ASSOC. DISPOSABLE ILL ENDOCULAR LASER PROBE (K954306)Gamp & Assoc.1995-12-22

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
ND:YAG POSTERIOR CAPSULOTOMY MODEL 100 (P830062/S016)Nidek, Inc.1990-03-13
ND:YAG POSTERIOR CAPSULOTOMY MODEL 100 (P830062/S015)Nidek, Inc.1989-09-08
ND:YAG POSTERIOR CAPSULOTOMY MODEL 100 (P830062/S014)Nidek, Inc.1989-08-30
ND:YAG POSTERIOR CAPSULOTOMY MODEL 100 (P830062/S012)Nidek, Inc.1988-07-28
ND:YAG POSTERIOR CAPSULOTOMY MODEL 100 (P830062/S011)Nidek, Inc.1987-06-11
ND:YAG POSTERIOR CAPSULOTOMY MODEL 100 (P830062/S009)Nidek, Inc.1987-04-08
ND:YAG POSTERIOR CAPSULOTOMY MODEL 100 (P830062/S010)Nidek, Inc.1986-12-01
ND:YAG POSTERIOR CAPSULOTOMY MODEL 100 (P830062/S007)Nidek, Inc.1985-11-26