510(k) K951437
- Device
- OTI MODEL TLS-60
- Applicant
- OTI MEDICAL LLC.
- 510(k) number
- K951437
- Product code
- HPC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1995-04-11
- Date received
- 1995-03-27
- Regulation
- 886.1405
- Classification name
- Set, Lens, Trial, Ophthalmic
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- WILL MARKLE
- Address
- 530 Bercut Dr. Suiter J Sacramento CA US 95814 95814
FDA Registration Numbers#
- 3004441848
- 3007123908
- 8040382
- 3009515444
- 9611269
- 3010508185
- 3015533540
- 3033566
- 3003846146
- 9614661
- 3010774780
- 1122810
- 3004095901
- 9617768
- 3009518015
- 3008197763
- 1836161
- 3004571972
- 3012796531
- 1053053
- 3009275598
- 3011659880
- 3011898560
- 3007817024
- 2085143
- 3003951061
- 3013846070
- 1937310
- 9612297
- 3042228518
- 3014326859
- 3005785090
- 3007343325
- 3006550126
- 1319721
- 3009132348
- 1820463
- 2086350
- 3003039352
- 8043467
- 3017774717
- 3020723591
- 5470
- 3003860739
- 3003860763
- 1418300
- 3003144305
- 3013436538
- 1045379
- 8030207
- 3004784203
- 3002499749
- 9613910
- 8040381
- 2031962
- 3001762432
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HPC #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K945443 | BOBES LENS SET | Bobes S.A. | 1995-07-19 |
| K930195 | OPHTHALMIC TRIAL LENSES | Optimark Accessories and Instruments | 1994-01-06 |
| K934859 | CONTACT LENSES | Arno Intl., Inc. | 1993-12-21 |
| K930446 | MARCO TRIAL SETS | Marco Ophthalmic, Inc. | 1993-07-06 |
| K924786 | BURTON TRIAL LENS SET | R.H. Burton Co. | 1993-04-14 |
| K920571 | TRIAL LENS SET | R.H. Burton Co. | 1992-05-07 |
| K900478 | WOODLYN FULL APERTURE TRIAL LENS SET | Woodlyn, Inc. | 1990-02-21 |
| K873907 | CONFIRMATION TESTS | Richmond Products, Inc. | 1987-12-29 |
| K852056 | ACC CROSS CYLINDERS | Ascon Medical Instruments, Ltd. | 1985-06-05 |
| K843095 | TRIA LENS SET | Optek Medico Co., Ltd. | 1984-10-05 |
| K841766 | WOODLYN CLASSIC TRIAL LENS SET | Woodlyn, Inc. | 1984-06-01 |
| K770389 | LENS SET, MENTOR TRIAL | Codman & Shurtleff, Inc. | 1977-03-14 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases