FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens, Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Astigmatism, and, Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia
K Number: K220613
·
Decision Mar 8, 2023
Classifications
1
FEI Numbers
130
Registration Numbers
130
Same Product Code
485
Applicant Total
23
Review Days
370
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Basic Information
- Device Name
- Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens, Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Astigmatism, and, Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia
- K Number
- K220613
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.5925
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bausch & Lomb, Incorporated
- Date Received
- March 3, 2022
- Decision Date
- March 8, 2023
- Product Code
- LPL
- 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 |
|---|---|---|---|
| LPL | Lenses, Soft Contact, Daily Wear | FDA class 2 | Ophthalmic |
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Other Clearances by Bausch & Lomb, Incorporated
| K Number | Device Name | ||
|---|---|---|---|
| K242389 | EyeGility Inserter for Preloaded enVista IOLs | Oct 10, 2024 | Substantially Equivalent |
| K222541 | Bausch + Lomb Preservative Free Lubricating and Rewetting Drops | Dec 6, 2022 | Substantially Equivalent |
| K202932 | ABT12 multi-purpose solution | May 28, 2021 | Substantially Equivalent |
| K210975 | Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia | May 24, 2021 | Substantially Equivalent |
| K200416 | Boston One Step Liquid Enzymatic Cleaner | Sep 23, 2020 | Substantially Equivalent |
| K183167 | Boston ES (enflufocon A) Rigid Gas Permeable Contact Lens; Boston EO (enflufocon B) Rigid Gas Permeable Contact Lens; Boston XO (hexafocon A) Rigid Gas Permeable Contact Lens; Boston XO2 (hexafocon B) Rigid Gas Permeable Contact Lens | Feb 12, 2019 | Substantially Equivalent |
| K182249 | Ultra (samfilcon A) Multifocal for Astigmatism Contact Lens | Nov 30, 2018 | Substantially Equivalent |
| K181627 | Bausch + Lomb Boston SimplusMulti-Action Solution, Bausch + Lomb Boston One Step Liquid Enzymatic Cleaner | Aug 10, 2018 | Substantially Equivalent |
| K173089 | Bausch + Lomb Boston Original Cleaner, Bausch + Lomb Boston Original Conditioning Solutions | Nov 27, 2017 | Substantially Equivalent |
| K173365 | Bausch + Lomb Boston Scleral Lens Case | Nov 17, 2017 | Substantially Equivalent |