Atlas FDA

THE OCUPLOT D

FDA 510(k) clearance K822415 · decided 1982-09-07

Clearance details

K-number
K822415
Device name
THE OCUPLOT D
Applicant
Coherent Medical Division
Decision
Substantially Equivalent
Date received
1982-08-11
Decision date
1982-09-07
Days to decision
27 days
Clearance type
Traditional
Product code
HPJ
Device class
2
Regulation number
886.1360
Medical specialty
Ophthalmic
Advisory committee
Ophthalmic
Location
Mchenry, IL, US
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
IRAS PERIMETER (K864012)Randwal Instrument Co., Inc.1986-12-12
LASER IRAS (K853556)Randwal Instrument Co., Inc.1985-11-01
LASER PHOTOCOAGULATOR ARGON MED. LASER (K813429)American Laser Corp.1982-01-22
RETINOMETER (K781507)Coburn Optical Ind., Inc.1978-11-15

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
NEODYMIUM: YAG OPHTHALMIC LASER SYSTEM 9900 (P830054/S022)Coherent Medical Division1989-08-29
NEODYMIUM: YAG OPHTHALMIC LASER SYSTEM 9900 (P830054/S021)Coherent Medical Division1988-08-30
NEODYMIUM: YAG OPHTHALMIC LASER SYSTEM 9900 (P830054/S020)Coherent Medical Division1987-12-01
NEODYMIUM: YAG OPHTHALMIC LASER SYSTEM 9900 (P830054/S019)Coherent Medical Division1987-07-21
NEODYMIUM: YAG OPHTHALMIC LASER SYSTEM 9900 (P830054/S018)Coherent Medical Division1987-05-19
NEODYMIUM: YAG OPHTHALMIC LASER SYSTEM 9900 (P830054/S017)Coherent Medical Division1987-03-31
NEODYMIUM: YAG OPHTHALMIC LASER SYSTEM 9900 (P830054/S015)Coherent Medical Division1986-12-01
NEODYMIUM: YAG OPHTHALMIC LASER SYSTEM 9900 (P830054/S009)Coherent Medical Division1986-11-07