510(k) K882308
- Device
- Cr-39 Plastic Lenses For Eyeglasses
- Applicant
- AUTOMATED LENS SYSTEM
- 510(k) number
- K882308
- Product code
- HQG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-07-22
- Date received
- 1988-06-03
- Regulation
- 886.5844
- Classification name
- Lens, Spectacle, Non-Custom (Prescription)
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- MICHAEL WALACH
- Address
- 6376 SW 10 Ter. Miami FL US 33144 33144
FDA Registration Numbers#
- 3015335936
- 2087075
- 1218954
- 3023010371
- 3043648613
- 3015534053
- 3015446923
- 3010804899
- 3030492158
- 3007421138
- 3015391081
- 3009831516
- 3006731548
- 3008939601
- 3030089831
- 3030221389
- 1000189446
- 1937310
- 3005246919
- 3010408842
- 3004551316
- 3023322473
- 9614727
- 3004521931
- 3012307978
- 9615473
- 3006946094
- 8031574
- 3013170369
- 3015534032
- 3006752097
- 3012879963
- 3014020412
- 3010399203
- 2124545
- 3005519018
- 1000253285
- 9617875
- 3015308733
- 3014889445
- 3042896809
- 3003871690
- 3017358759
- 3009233789
- 9680616
- 3014343954
- 3005785003
- 1317695
- 3004443844
- 3001135633
- 2432297
- 3016595584
- 3010183187
- 9615499
- 3021244189
- 3004138487
- 3033777988
- 3007675955
- 3010923108
- 1000158117
- 8043274
- 3012110814
- 1225043
- 3010229247
- 3012796531
- 3004573418
- 3012297893
- 8021087
- 3007774542
- 9680346
- 3008370976
- 3003344414
- 9681443
- 3007793466
- 8040222
- 3012981754
- 3043105510
- 8043775
- 3014308107
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HQG#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K935919 | SUNGLASSES | Ja-Ru, Inc. | 1994-02-16 |
| K920795 | 0R 160, OR-1.60, AND ORCOLITE 1.60 HIGH INDEX | Optical Radiation Corp. | 1992-07-13 |
| K900091 | MODIFIED OPHTHALMIC OPIR ONUFRYK IMAGE DEFLECTOR | Onufryk Low Vision Ent. | 1990-04-04 |
| K884360 | SEIKO P-6 PROGRESSIVE SPECTACLE LENSES | Seiko Corp. | 1988-11-15 |
| K882814 | NEOLENS PRESCRIPTION SPECTACLE LENS | Neolens, Inc. | 1988-07-29 |
| K881225 | OPHTHALMIC SPECTACLE LENS BLANKS | Beta Optical Co, Inc. | 1988-04-19 |
| K875063 | SEIKO PLAX DIACOAT II & SEIKO PLAX S.V.P. | Epson EL Paso, Inc. | 1988-02-22 |
| K874681 | SWIRL - A PRE-MOISTENED CLEANING TISSUE FOR EYES | Klockner Contract Packaging, Inc. | 1988-02-05 |
| K873245 | AR DIACOAT SINGLE VISION LENSES | Seiko Optical Products of America, Inc. | 1987-10-05 |
| K872506 | MELANITE I | Aura Lens Products | 1987-07-27 |
| K871961 | MULTIPLE SPECTACLE LENS | Korea Asahi Optical Co., Ltd. | 1987-06-03 |
| K865103 | KROM-X LENS SYSTEM | Neo Optics, Inc. | 1987-01-20 |
| K863367 | FORMALENS 2000 | Vision-Sciences, Inc. | 1986-09-26 |
| K862578 | TECHNA VISION CASTING RESIN | Techna Vision | 1986-07-23 |
| K861021 | GOTTEX SUNGLASSES | Private Eyes Sunglass Corp. | 1986-06-17 |