List of FDA-Approved Lasers for LASIK (2024)

FAQs

Which lasers are FDA approved? ›

LASIK uses Excimer LASER which is an extremely controlled, specialized beam of ultraviolet light. The computer controlled LASER beam reshapes the corneal curvature in a highly precise and predetermined pattern so that it can now focus the light on the Retina.

According to the FDA, loss of vision, corneal complications, retinal detachment, dry eyes, pain, double vision, drooping eyelid, and visual symptoms, such as seeing glare, halos, or starbursts, are some potential side effects. There is also a potential risk of psychological harm.

Your Vision is Measured in Diopters

The Food and Drug Administration (FDA) has clearly defined parameters for LASIK eye surgery, which include: Nearsightedness (myopia) up to -12.00 diopters. Farsightedness (hyperopia) up to +6.00 diopters. Astigmatism up to 6 diopters.

The Food and Drug Administration (FDA) recognizes four major hazard classes (I to IV) of lasers, including three subclasses (IIa, IIIa, and IIIb). The higher the class, the more powerful the laser and the potential to pose serious danger if used improperly.

If you identify a similar device legally marketed in the United States, you may search for an FDA letter or order that permits market authorization. The information in the letter or order for a similar device type might help you determine the classification of your device.

These include market saturation, overexposure of LASIK's complications by the media and government agencies, and changes in demographics and culture. The combination of these factors has sullied the image of LASIK, and as a result, the market will never return to the same level of procedures as in 2007.

Photorefractive keratectomy

Vision improvement with PRK is similar to that of LASIK. PRK may be a better option than LASIK for people with thin or flat corneas, or for athletes and those with an active lifestyle or career (such as a pilot or race car driver) who are concerned about dislodging the flap after surgery.

The LASIK complication rate is only about 0.3%. The most commonly reported LASIK complications are infection or dry eye that persists for more than six months. Other complications include: Undercorrections occur when the laser removes too little tissue.

So what prescription is too high for LASIK? Many eye doctors will set their limits to +6 for farsightedness, -12 for nearsightedness, and 6 diopters for astigmatism. But there are other factors that can make some patients good for LASIK while others are disqualified from the procedure.

What eyesight is not eligible for LASIK? ›

LASIK works for mild-to-severe nearsightedness and mild-to-moderate farsightedness and astigmatism. If you don't meet one or more of these criteria, you're not a good candidate, and you'll need to explore other options.

More than 95% of participants were satisfied with their vision following LASIK surgery. Participants were more than twice as likely to report their visual symptoms on a questionnaire than to tell them to their health care provider.

Under federal law, it is perfectly legal to sell any laser above 5 mW as long as the laser complies with FDA/CDRH laser product requirements for labels, safety features, quality control, etc. AND as long as the laser is not promoted as a “laser pointer” or for pointing purposes.

Candela™ GentleLASE®, Cynosure™ Apogee Elite® and Cutera™ CoolGlide® technologies are medical grade lasers that are manufactured in America and are FDA approved. Velvet Effect Lasers only use Candela™, Cynosure™ and Cutera™ technologies, not IPLs.

The Original LaserCap HD+ kit. FDA-cleared laser therapy for male and female pattern hair loss. The LaserCap HD+ contains 304 laser diodes, delivering prescription-strength, 3.93 J/cm² dose of light energy to the hair follicles.

A Class 1 laser is safe under all conditions of normal use. This means the maximum permissible exposure (MPE) cannot be exceeded when viewing a laser with the naked eye or with the aid of typical magnifying optics (e.g. telescope or microscope).