FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
FLUOROPERM 151-OK, PARAGON HDS 100-OK
K Number: K010109
·
Decision Feb 28, 2001
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
5
Applicant Total
15
Review Days
47
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Basic Information
- Device Name
- FLUOROPERM 151-OK, PARAGON HDS 100-OK
- K Number
- K010109
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.5916
- Medical Specialty
- Ophthalmic
- Decision
- Unknown
- Statement or Summary
- Summary
- Applicant
- Paragon Vision Sciences
- Date Received
- January 12, 2001
- Decision Date
- February 28, 2001
- Product Code
- MUW
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MUW | Lens, Contact (Orthokeratology) | FDA class 2 | Ophthalmic |
Similar 510(k) Clearances
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OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E)
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BOSTON EQUALENS II (OPRIFOCON A) CONTACT LENS FOR ORTHOKERATOLGY
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FLUROPERM 60-OK, PARAGON HDS-OK
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AIRPERM (SIFLUFOCON A) RIGID GAS PERMEABLE OK CONTACT LENSES FOR DAILY WEAR ORTHOKERATOLOGY
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Other Clearances by Paragon Vision Sciences
| K Number | Device Name | ||
|---|---|---|---|
| K180172 | FluoroPerm 30 & Paragon Thin (paflufocon C) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 60 & Paragon HDS (paflufocon B) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 92 (paflufocon A) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 151 & Paragon HDS 100 (paflufocon D) RGP contact lenses with Tangible Hydra-PEG | Mar 16, 2018 | Substantially Equivalent |
| K120996 | FLUOROPERM 30 PARAGON HDS FLUOROPERM 60 PARAGON HDS 100 FLUOROPERM 92 FLUOROPERM 151 PARAGON THIN | Jun 28, 2012 | Substantially Equivalent |
| K082799 | HDS HI 1.54 | Jan 27, 2009 | Substantially Equivalent |
| K070637 | FLUOROPERM 92, 60, 30 AND 151 AND PARAGON HDS, HDS 100 AND THIN RIGID GAS PERMEABLE CONTACT LENSES | May 1, 2007 | Substantially Equivalent |
| K052983 | FLUOROPERM 151 (PAFLUFOCON D) AND PARAGON HDS 100 (PAFLUFOCON D) RIGID GAS PERMEABLE CONTACT LENSES | Feb 10, 2006 | Substantially Equivalent |
| K013310 | PVS BASIC 2; EPIC 2 | Apr 25, 2002 | Substantially Equivalent |
| K002845 | PAFLUFOCON C AND E DAILY CONTACT LENS | Dec 8, 2000 | Substantially Equivalent |
| K993586 | SPORTSIGHT GP | May 22, 2000 | Substantially Equivalent |
| K000224 | FLUROPERM 60-OK, PARAGON HDS-OK | Apr 17, 2000 | Unknown |
| K993486 | PARAGON LENS CARRIER | Dec 22, 1999 | Substantially Equivalent |