510(k) K102266
- Device
- ISOLED AC-POWERED LED HEADLIGHT SYSTEM
- Applicant
- ISOLUX LLC
- 510(k) number
- K102266
- Product code
- FST
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2010-09-24
- Date received
- 2010-08-10
- Regulation
- 878.4580
- Classification name
- Light, Surgical, Fiberoptic
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- Yes
Applicant Contact#
- Contact
- NIKOLAUS ANDREOULAKIS
- Address
- 1045 Collier Center Way Suite #6 Naples FL US 34110 34110
FDA Registration Numbers#
- 1220246
- 2031966
- 3015967359
- 3009144915
- 3004719693
- 2183744
- 3006128100
- 3009973336
- 1526439
- 1000122786
- 3004024955
- 3003418325
- 1056553
- 1923569
- 3011373951
- 3015231789
- 1035968
- 3003755939
- 3010057495
- 3012447612
- 3016050940
- 1218017
- 3012329552
- 1222275
- 3006591312
- 3006498370
- 1037007
- 3021336182
- 1721676
- 3004893332
- 3015806723
- 1043572
- 1222928
- 3006697299
- 3007589150
- 3011050570
- 3021839632
- 3003935342
- 3010400367
- 3021393544
- 1226544
- 3007456622
- 3008114965
- 3014004349
- 1047843
- 2936485
- 1221934
- 3018094310
- 3016727307
- 2031093
- 3010393950
- 1421101
- 3009973505
- 3010331645
- 3012883081
- 3003768921
- 3006639944
- 3006142527
- 9611390
- 3027242374
- 3016438694
- 3004608878
- 3021226419
- 1045254
- 3030926959
- 3030412764
- 1319480
- 3005497913
- 3034676720
- 1928237
- 3006973663
- 3009420598
- 1017294
- 3020899789
- 3012470322
Source Documents#
Other 510(k) Records For Product Code FST #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K200874 | TruView Light Cable, TruView Lateral Retractor Light Cable, Bifurcated Light Cable With Universal End | Innovasis, Inc. | 2020-06-30 |
| K141330 | ENDO-CORD | Enroxtech, Inc. | 2014-12-15 |
| K122637 | LITE DECOMPRESSION SYSTEM- LIGHT CABLE MODEL 48089999 | Stryker Spine | 2012-11-01 |
| K113697 | EIGR SURGICAL ILLUMINATION SYSTEM | Invuity, Inc. | 2012-02-10 |
| K113330 | CABLECAP | Sensormed | 2012-01-12 |
| K101496 | CABLECAP MODEL: WLF, STZ, ACM | Sensormed | 2010-09-14 |
| K100388 | 21ST CENTURY CENTURION EXCELED AND SYSTEM TWO LED LIGHTING SYSTEMS | Medical Illumination International, Inc. | 2010-06-22 |
| K100395 | HARMONY VLED SURGICAL LIGHTNING SYSTEM | STERIS Corporation | 2010-03-17 |
| K093386 | CHROMALUME TURBO LIGHT SOURCE WITH XTREMEBEAM FIBER OPTIC HEADLAMPFST MODEL FST | Bfw, Inc. | 2010-01-28 |
| K090070 | INVUITY BRITEFIELD MCCULLOCH RETRACTOR SYSTEM | Invuity, Inc. | 2009-04-22 |
| K083710 | RETRACTOR LITE | Thomas Surgical Instruments, Inc. | 2009-02-23 |
| K082992 | AXXION LIGHT GUIDE | Spinal Elements, Inc. | 2009-02-18 |
| K080962 | LITE WAND II | Thompson Surgical Instruments, Inc. | 2008-06-25 |
| K080367 | ZIMMER MIS LIGHT | Zimmer Spine, Inc. | 2008-02-22 |
| K071218 | PROXENON 350, MODEL 902XX | Welch Allyn, Inc. | 2007-06-14 |
Legacy Summary#
summary
FDA Review#
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