510(k) K023939
- Device
- VELOCITY ADVANTAGE
- Applicant
- Visioncare Devices, Inc.
- 510(k) number
- K023939
- Product code
- HQE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2003-04-17
- Date received
- 2002-11-26
- Regulation
- 886.4150
- Classification name
- Instrument, Vitreous Aspiration And Cutting, Ac-Powered
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- N
Applicant Contact#
- Contact
- CHET CRACCHIOLO
- Address
- 1246 Redwood Blvd. Redding CA US 96003 96003
FDA Registration Numbers#
- 2529392
- 3003398873
- 1644019
- 3010208880
- 3010220595
- 2935428
- 1920664
- 9681121
- 2246552
- 3007648309
- 3006946276
- 3015456951
- 1313525
- 2028159
- 1722139
- 3019924
- 9611516
- 2028523
- 3009039068
- 2953359
- 1932402
- 1047843
- 3005941719
- 3002907620
- 3009337401
- 3042928348
- 8030967
- 2523835
- 1932180
- 9615010
- 1526711
- 1928237
- 3005012805
- 3002807090
- 1650907
- 3010291427
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HQE#
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|---|---|---|---|
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| K153168 | Bi-Blade Vitrectomy Cutter | Medical Instrument Development Laboratories | 2016-04-29 |
| K141065 | CONSTELLATION VISION SYSTEM | Alcon Research, Ltd. | 2014-08-22 |
| K121675 | VERSAVIT | Synergetics, Inc. | 2012-06-21 |
| K120170 | PROCARE PLUS VITRECTOMY SYSTEM | Visioncare Devices, Inc. | 2012-05-30 |
| K102222 | ULTIMATE VIT ENHAMCER (UVE) | Medical Instrument Development Laboratories, Inc. | 2011-04-08 |
| K033390 | COLIBRI DISPOSABLE VITRECTOMY CUTTER | Microworld Medical Instruments, Inc. | 2003-11-04 |
| K030948 | VMATE MODEL VMM1000 | Howard Instruments, Inc. | 2003-06-17 |
| K020911 | MID LABS AUTONOMOUS VIT ENHANCER (AVE) | Medical Instrument Development Laboratories, Inc. | 2002-04-29 |
| K010082 | D.O.R.C. HARMONY TOTAL TTC VITRECTOMY SYSTEM | Dutch Ophthalmic USA, Inc. | 2001-03-12 |
| K992943 | VIT ENHANCER | Medical Instrument Development Laboratories, Inc. | 1999-12-10 |
| K990292 | I/A (IRRIGATION/ASPIRATION) PACK, POSTERIOR VITRECOMY PACK, ANTERIOR VIRECTOMY PACK, PHACOEMULSIFICATION PACK, ADMIINISN | Ophthalmic Consultants, Inc. | 1999-11-19 |
| K983797 | D.O.R.C. HARMONY TOTAL VITRECTOMY SYSTEM | Dutch Ophthalmic USA, Inc. | 1999-03-03 |
| K980400 | PVRS-PEREGRINE VITREORETINAL SCISSOR MODEL PD505.10 | Peregrine Surgical , Ltd. | 1998-04-30 |