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Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)

Page Type
Product Code
Definition
The system consists of an intraocular lens and an external energy source. The lens is intended to be implanted to replace the natural lens of an eye. The external energy source is used to postoperatively alter the properties of the lens material to reduce the likelihood of clinically significant postoperative refractive error.
Physical State
An intraocular lens made of a polymeric material with an appropriate shape to be implanted to replace the natural lens of an eye after cataract surgery. The energy source is a device that produces an appropriate external energy source to alter the shape or optical properties of the lens.
Technical Method
The intraocular lens is implanted within the eye and the external energy source is used to alter the material property within the lens to compensate for postoperative refractive error.
Target Area
Eye
Regulation Medical Specialty
Ophthalmic
Review Panel
Ophthalmic
Submission Type
PMA
Device Classification
Class 3
Regulation Number
886.3600
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
Yes
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 886.3600 Intraocular lens

§ 886.3600 Intraocular lens.

(a) Identification. An intraocular lens is a device made of materials such as glass or plastic intended to be implanted to replace the natural lens of an eye.

(b) Classification. Class III.

(c) Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before this device may be commercially distributed. See § 886.3.

Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)

Page Type
Product Code
Definition
The system consists of an intraocular lens and an external energy source. The lens is intended to be implanted to replace the natural lens of an eye. The external energy source is used to postoperatively alter the properties of the lens material to reduce the likelihood of clinically significant postoperative refractive error.
Physical State
An intraocular lens made of a polymeric material with an appropriate shape to be implanted to replace the natural lens of an eye after cataract surgery. The energy source is a device that produces an appropriate external energy source to alter the shape or optical properties of the lens.
Technical Method
The intraocular lens is implanted within the eye and the external energy source is used to alter the material property within the lens to compensate for postoperative refractive error.
Target Area
Eye
Regulation Medical Specialty
Ophthalmic
Review Panel
Ophthalmic
Submission Type
PMA
Device Classification
Class 3
Regulation Number
886.3600
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
Yes
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 886.3600 Intraocular lens

§ 886.3600 Intraocular lens.

(a) Identification. An intraocular lens is a device made of materials such as glass or plastic intended to be implanted to replace the natural lens of an eye.

(b) Classification. Class III.

(c) Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before this device may be commercially distributed. See § 886.3.