510(k) K884694
- Device
- MQL 20 ND:YAG OPHTHALMIC LASER
- Applicant
- CALIFORNIA LABORATORIES, INC.
- 510(k) number
- K884694
- Product code
- LQJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-11-30
- Date received
- 1988-11-09
- Regulation
- 886.4390
- Classification name
- Lens, Surgical, Laser, Accesssory, Ophthalmic Laser
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- KENNETH R MICHAEL
- Address
- 5964 La Pl. Ct. Carlsbad CA US 92008 92008
FDA Registration Numbers#
- 3007589150
- 1928237
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LQJ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K163632 | Katalyst Cyclophotocoagulation Probe | Katalyst Surgical, LLC | 2017-06-15 |
| K931356 | SAFE AIR VARI-SPOT HANDPIECE TELESCOPE AND ADAPTOR | Sorenson Laboratories, Inc. | 1993-09-07 |
| K921414 | TROKEL /3 GONIO LASER LENS | Ocular Instruments, Inc. | 1992-11-16 |
| K912112 | PF-400,GF-300,IF-200,PG400,PG400C,AND ED-480 | Tomey Corporation USA | 1991-06-17 |
| K893731 | SHIELDS T.C. LASER LENS | Ocular Instruments, Inc. | 1989-08-17 |
| K883719 | INTERCONN. OF OPHTHALAS & NANOLAS LASER SYSTEM | Biophysic Medical, Inc. | 1988-10-18 |
| K883270 | IRIS ND:YAG OPTHALMIC LASER | California Laboratories, Inc. | 1988-10-13 |
| K882574 | BOLDREY PERIPHERAL RETINAL LENS | Ocular Instruments, Inc. | 1988-07-29 |
| K872802 | TROKEL SINGLE MIRROR YAG LASER LENS | Ocular Instruments, Inc. | 1987-09-04 |
| K871245 | LASER CONTACT LENSES CGA 1, CGI 1, CGP 1, CGV 1 | Chiron Vision Corp. | 1987-05-07 |
| K871099 | SCHIRMER NYLON SUTURE LASER LENS | Ocular Instruments, Inc. | 1987-04-27 |
| K862869 | PETRUS SINGLE MIRROR LASER LENS | Ocular Instruments, Inc. | 1986-08-21 |
Legacy Summary#
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FDA Review#
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