The FDA warns that some doctors in the United States are using "black boxes" - lasers manufactured and illegally sold in the United States - despite their unproven safety record and lack of FDA clearance. There are also doctors using "gray market" lasers - lasers imported from outside the United States that had not earned FDA approval. These lasers were legally exported to other countries but never received FDA approval for use within the United States. Third parties then illegally sold these lasers back into the United States.
Outside of clinical trials, it is illegal in the United States to use lasers that have not received FDA approval. However, due to the fact that the FDA has limited resources to track the use of such lasers it is up to the patients to do their homework and question the doctors. The US FDA provides a listing of excimer lasers approved for refractive surgery on their LASIK website. If you reside within the United States, your surgeon should not be using a laser other than those listed.
|
Company and model
|
Approval number and date
|
Approved indications
(D = diopters)
|
Autonomous Technology
- LADARVision
|
5/9/00 |
Myopia less than -9.0D with or without astigmatism
from -0.5 to -3.0D
|
Bausch & Lomb Surgical
- Technolas 217a
|
2/23/00 |
Myopia from -1.0 to -7.0D with or without astigmatism
less than -3.0D |
| Dishler |
12/16/99 |
Myopia from -0.5 to -13.0D with or without astigmatism
-0.5 to -4.0D
|
| Kremer |
7/30/98 |
Myopia from -1.0 to -15.0D with or without astigmatism up to -5.0D
|
LaserSight
- LaserScan LSX |
9/28/01 |
Myopia from -0.5 to -6.0D with or without astigmatism
up to 4.5D |
Nidek
- EC5000 |
4/14/00 |
Myopia from -1.0 to -14.0D with or without astigmatism
less than 4.0D
|
Summit
- Apex Plus |
10/21/99 |
Myopia less than -14.0D with or without astigmatism
from 0.5 to 5.0D
|
Summit Autonomous
- LADARVision |
9/22/00 |
Hyperopia less than 6.0D with or without astigmatism
less than -6.0D
|
VISX
- Star S2 & S3 |
4/27/01 |
Hyperopia between +0.5 and +5.0D with or without
astigmatism up to +3.0D
|
VISX
- Star S2 & S3 |
11/16/01 |
Mixed
astigmatism up to 6.0D; cylinder is greater than sphere and of opposite
sign |
VISX
- Star S2 |
11/19/99 |
Myopia less than -14.0D with or without astigmatism
between -0.5 and -5.0D
|
VISX
- Star S3 (EyeTracker) |
4/20/00
4/27/01 |
Same as S2, except with eye tracker
|
