• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Recognized Consensus Standards

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 

New Search Back To Search Results
Recognition List Number: 034 FR Publication Date: 01/30/2014 

Part B: Supplementary Information

Recognition Number 10-83: ISO 18369-1 First edition 2006-08-15, ophthalmic optics -- contact lenses -- part 1: vocabulary, classification system and recommendations for labeling specifications [including: amendment 1 (2009)]. (Ophthalmic)

Date of Standard: 2006. 
Address of Standards Development Organization:
 International Organization for Standardization (ISO)*
  1, Rue de Varembe
  Case Postale 56
  CH 1211 Geneva 20, 0
  SWITZERLAND
CDRH Office and Division associated with recognized standards:
OFFICE OF DEVICE EVALUATION (ODE)
DIVISION OF OPHTHALMIC AND EAR, NOSE AND THROAT DEVICES (DOED)
Devices Affected:
Contact lenses
Processes Affected:
510(k), PMA, IDE, PDP, HDE Design Control Input
Type of Standard:
 Vertical, International
Extent of Recognition:
Complete standard and any annexes.
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§886.5916 Lens, Contact (Orthokeratology) Class 2 MUW
§886.5916 Lens, Contact (Other Material) - Daily Class 2 HQD
§886.5916 Lens, Contact, Orthokeratology, Overnight Class 3 NUU
§886.5916 Lens,Contact(Rigid Gas Permeable)-Extended Wear Class 3 MWL
§886.5925 Lens, Contact, (Disposable) Class 2 MVN
§886.5925 Lens, Contact, For Color Vision Deficiency Class 2 NCZ
§886.5925 Lens, Contact, For Reading Discomfort Class 2 NIC
§886.5925 Lenses, Soft Contact, Daily Wear Class 2 LPL
§886.5925 Lenses, Soft Contact, Extended Wear Class 3 LPM
§886.5925 System,In-Office Tinting,Contact Lenses Class 2 MZD
Relevant Guidance:
Premarket Notification (510(k)) Guidance Document for Daily Wear Contact Lenses, Issued May 1994

Green, J.A., Phillips, K.S., Hitchins, V.M., Lucas, A.D., Shoff, M.E., Hutter, J.C., Rorer, E.M., & Eydelman, MB. (2012). Material properties that predict preservative uptake for silicone hydrogel contract lenses. Eye and Contact Lens, 38 (6), 350-357.

Hutter, J.C., Green, J.A., & Eydelman, M.B. (2012). Proposed Silicone Hydrogel Contact Lens Grouping System for Lens Care Product Compatibility Testing. Eye and Contact Lens, 38(6), 358-362.
FDA Technical Contact:
 Joseph C. Hutter
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room 2458
  Silver Spring MD 20993
  301/796-6499
  email: joseph.hutter@fda.hhs.gov
* in the United States, copies of this standard can be obtained from:
  American National Standards Institute (ANSI)*
  25 West 43rd Street
  4th Floor
  New York, NY 10036
-
-