510(k) K901016
- Device
- LASER-SHIELD II(TM)
- Applicant
- XOMED, INC.
- 510(k) number
- K901016
- Product code
- GEX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-08-29
- Date received
- 1990-03-05
- Regulation
- 878.4810
- Classification name
- Powered Laser Surgical Instrument
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- DONALD R BRUCE
- Address
- 6743 Southpoint Dr. N. Jacksonville FL US 32216 32216
FDA Registration Numbers
- 3038715747
- 1725006
- 3018116888
- 3013917867
- 3023344923
- 3030495752
- 1054713
- 3030233762
- 3011657089
- 3010060157
- 1221275
- 3012452798
- 3019906161
- 2438558
- 2183744
- 3020611964
- 2939653
- 3009039068
- 3030230686
- 3008805497
- 1216677
- 3005801723
- 3003610374
- 2938071
- 3032916575
- 1313525
- 3011050570
- 3003015433
- 3013376016
- 3015392301
- 3020770009
- 8044098
- 2027755
- 3009488834
- 3011302631
- 3008442971
- 1064858
- 1225072
- 3002807314
- 1045254
- 1419489
- 3017124433
- 3043011436
- 3030733800
- 3004378299
- 3013602304
- 8021543
- 8040564
- 3016453004
- 3007336385
- 3043047259
- 3009649442
- 1723170
- 1226486
- 3017200975
- 3011743768
- 3013041594
- 3006368133
- 3015313684
- 3029083714
- 3014561425
- 3036240802
- 3016413636
- 3008915316
- 3016170453
- 3021550489
- 3009298127
- 3014980477
- 3005210579
- 2032112
- 3016830208
- 2954354
- 3011670002
- 9610617
- 3034630389
- 3009462521
- 3008925277
- 2953684
- 3042261306
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF not indicated by FDA · openFDA JSON
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00681490156080 | Laser-Shield® | MEDTRONIC XOMED, INC. | 2016-05-05 |
| 00681490156073 | Laser-Shield® | MEDTRONIC XOMED, INC. | 2016-05-05 |
| 00681490156066 | Laser-Shield® | MEDTRONIC XOMED, INC. | 2016-05-05 |
| 00681490156059 | Laser-Shield® | MEDTRONIC XOMED, INC. | 2016-05-05 |
| 00681490156042 | Laser-Shield® | MEDTRONIC XOMED, INC. | 2016-05-05 |
| 00681490156035 | Laser-Shield® | MEDTRONIC XOMED, INC. | 2016-05-05 |
| 00681490156028 | Laser-Shield® | MEDTRONIC XOMED, INC. | 2016-05-05 |
| 00681490156011 | Laser-Shield® | MEDTRONIC XOMED, INC. | 2016-05-05 |
| 00681490155946 | Laser-Shield® | MEDTRONIC XOMED, INC. | 2016-05-05 |
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