|
Company and model |
Approval number and date |
Approved indications (D = diopters) |
Bausch & Lomb Surgical - KERACOR 116 |
P970056 9/28/99 |
PRK; Myopia from -1.5 to -7.0D with or without astigmatism less than -4.5D |
Autonomous Technology - LADARVision |
P970043 11/2/98 |
PRK; Myopia from -1.0 to -10.0D with or without astigmatism less than -4.0D |
LaserSight - LaserScan LSX |
P980008 11/12/99 |
PRK; Myopia from -1.0 to -6.0D with or without astigmatism less than 1.0D |
Nidek - EC5000 |
P970053 12/17/98 |
PRK; Myopia from -0.75 to -13.0D |
Nidek - EC5000 |
P970053/S1 9/29/99 |
PRK; Myopia from -1.0 to -8.0D with or without astigmatism from -0.5 to -4.0D |
Summit - Apex & Apex Plus |
P930034 10/25/95 |
PRK; Myopia from -1.5 to -7.0D |
Summit - Apex Plus |
P930034/S9 3/11/98 |
PRK; Myopia from -1.0 to -6.0D with or without astigmatism from -1.0 to -4.0D |
Summit - Apex Plus |
P930034/S12 10/21/99 |
PRK; Hyperopia from +1.5 to +4.0D with or without astigmatism less than -1.0D |
Summit Autonomous - LADARVision |
P970043/S8 7/11/00 |
Name Change Only |
Sunrise - Hyperion |
P990078 6/30/00 |
Laser Thermokeratoplasty (LTK); Hyperopia from +0.75 to +2.5D with or without astigmatism less than 0.75D |
VISX - Model B & C (Star & Star S2) |
P930016 3/27/96 |
PRK; Myopia from 0 to -6.0D |
VISX - Model B & C (Star & Star S2) |
P930016/S3 4/24/97 |
PRK; Myopia from 0 to -6.0D with or without astigmatism from -0.75 to -4.0D |
VISX - Model B & C (Star & Star S2) |
P930016/S5 1/29/98 |
PRK; Myopia from 0 to -12.0D with or without astigmatism from 0 to -4.0D |
VISX - Star S2 |
P930016/S7 11/2/98 |
PRK; Hyperopia from +1.0 to +6.0D |
VISX - Star S3 (EyeTracker) |
P990010/S1 4/20/00 |
Same as S2, except with eye tracker |
VISX - Star S2 & S3 |
P930016/S10 10/18/00 |
PRK; Hyperopia from +0.5 to +5.0D with or without astigmatism +0.5 to +4.0D |