510(k) K852404
- Device
- LASERSAFE EYE SHIELDS
- Applicant
- LASERSAFE, INC.
- 510(k) number
- K852404
- Product code
- HOY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1985-10-04
- Date received
- 1985-06-06
- Regulation
- 886.4750
- Classification name
- Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear)
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- TEEPLE, M.D.
- Address
- 641 Ridgefield Ave. Pittsburgh PA US 15216 15216
FDA Registration Numbers#
- 3008466086
- 1419844
- 3046007776
- 3023812384
- 3038284246
- 9615527
- 3009596133
- 3004095901
- 3012796531
- 1920664
- 3027605742
- 9681464
- 3009420946
- 3008352964
- 3010027944
- 3021982899
- 3007593903
- 3004784770
- 3043648115
- 3017104073
- 3005067827
- 3005528784
- 1720839
- 3014268398
- 3007710647
- 3017303999
- 3001650535
- 3016171836
- 3012978407
- 3009648765
- 3008410069
- 3005670227
- 3014314985
- 1937310
- 3011310668
- 3014620201
- 3008044484
- 3018074459
- 8031054
- 3007851054
- 3012477715
- 3013091260
- 3042284353
- 3015895045
- 3021314602
- 3007620166
- 3013293162
- 3003491259
- 2135339
- 1641907
- 3038613785
- 3015005459
- 3002499749
- 3011456684
- 3010052104
- 3005608257
- 3006621348
- 3009937681
- 3040278184
- 1043214
- 3043177860
- 3010952192
- 3009666019
- 1530671
- 1061927
- 3017206625
- 3009009512
- 3038191347
- 3038636181
- 3010613909
- 8040381
- 3004605493
- 3010184873
- 3010339057
- 3009233038
- 3008421850
- 3016775323
- 9681480
- 3007675967
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HOY #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K132042 | AMB101 SYSTEM, AMBLYZ, LCG SYSTEM, XPAND | X6d, Ltd. | 2014-04-28 |
| K050856 | LCG (LIQUIDE CRYSTAL GLASSES) SYSTEM | Ophthocare , Ltd. | 2005-05-31 |
| K971465 | NATIONAL MEDICAL HALTHCARE CUSTOM OPHTHALMIC KITS OR TRAYS | National Healthcare Mfg. Corp. | 1997-06-04 |
| K944700 | ARCTIC PREMIER SERIES | Sungold Eyewear, Inc. | 1994-12-22 |
| K944857 | GOGGLE SAFEGUARD | Sellstrom Mfg. Co. | 1994-12-15 |
| K945351 | SHIELD, EYE, OPHTHALMIC | Taiwan Eva Industrial Co., Inc. | 1994-12-13 |
| K945346 | MAKROLON 2405 GOGGLES (LIGHT AND DARK) | Universal Massage & Tanning, Inc. | 1994-11-22 |
| K942407 | AMCON SLIP IN MYDRIATIC SUNGLASSES | Amcon Laboratories, Inc. | 1994-06-06 |
| K941829 | SUN FILTERS/SHIELDS | Klinger Eye Shields, Inc. | 1994-05-17 |
| K930347 | SHAIDS PROTECTIVE GLASSES | Depuy, Inc. | 1994-04-29 |
| K940213 | UNIVERSAL CUSHIONED METAL EYE SHIELD | P.J. Products, Inc. | 1994-03-24 |
| K940275 | UNIVERSAL CUSHIONED POLYCARBONAT EYE SHIELD | P.J. Products, Inc. | 1994-03-24 |
| K930840 | POST-MYDS(TM) | Aukland Medical Plastics, Inc. | 1994-03-01 |
| K940095 | FOX EYE ALUMINUM SHIELD, OPHTHALMIC | P.J. Products, Inc. | 1994-03-01 |
| K931254 | GOGGLE SAFEGUARD | Sellstrom Mfg. Co. | 1993-11-12 |
Legacy Summary#
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FDA Review#
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