510(k) K132042
- Device
- AMB101 SYSTEM, AMBLYZ, LCG SYSTEM, XPAND
- Applicant
- X6D, LTD.
- 510(k) number
- K132042
- Product code
- HOY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2014-04-28
- Date received
- 2013-07-02
- 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
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- KAREL VAN GORP
- Address
- 21 Hanafa St. Zur- Moshe IL 42810 42810
FDA Registration Numbers#
- 3007255375
- 1123137
- 3015168603
- 2087075
- 9611385
- 3027209650
- 3017432615
- 3025759181
- 3015316279
- 3043648613
- 3007421138
- 3013735213
- 1060680
- 3008381128
- 3015391081
- 3009831516
- 2030616
- 3018074459
- 3015532203
- 8031054
- 3004022422
- 3010041511
- 8020547
- 3010675897
- 1226074
- 1937310
- 3023322473
- 3015384437
- 3014819517
- 3004521931
- 3020870564
- 3014937479
- 3010262284
- 3012251300
- 3017482348
- 9615473
- 3006946094
- 3007710647
- 3013170369
- 3025414363
- 3006752097
- 9615399
- 3014020412
- 3008044484
- 3010399203
- 3005519018
- 3006542501
- 1313525
- 3003862188
- 1641907
- 3005785003
- 3013426279
- 3016595584
- 8010704
- 3011164728
- 1064005
- 3006573171
- 3012316249
- 3026326493
- 3017104073
- 1022129
- 9680271
- 1225043
- 3012796531
- 2183416
- 3007774542
- 3009747810
- 9680346
- 9680515
- 3014444068
- 3016931719
- 3043105510
- 2529846
- 3015112437
- 3015058854
- 3007060769
- 3003835287
- 3004765453
- 3033707699
Source Documents#
Other 510(k) Records For Product Code HOY #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K940275 | UNIVERSAL CUSHIONED POLYCARBONAT EYE SHIELD | P.J. Products, Inc. | 1994-03-24 |
| K940213 | UNIVERSAL CUSHIONED METAL EYE SHIELD | P.J. Products, Inc. | 1994-03-24 |
| K940095 | FOX EYE ALUMINUM SHIELD, OPHTHALMIC | P.J. Products, Inc. | 1994-03-01 |
| K930840 | POST-MYDS(TM) | Aukland Medical Plastics, Inc. | 1994-03-01 |
| K934085 | MODIFICATION OF SURGICAL EYESHIELD MASK | American Threshold Industries, Inc. | 1993-11-12 |
| K931254 | GOGGLE SAFEGUARD | Sellstrom Mfg. Co. | 1993-11-12 |
Legacy Summary#
summary
FDA Review#
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