# K073184: Boston RGP Lenses Wet Shipped in Bostom Simplus Multi-Action Solution and Stored for UP to 30 Days

- Pathway: 510(k) (Abbreviated)
- Applicant: Bausch & Lomb, Inc.
- Decided: Feb 21, 2008 after 100 days
- Product code: HQD (Lens, Contact (Other Material) - Daily)
- Device class: 2
- Regulation: 21 CFR 886.5916
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K002025 (2000). 1 ancestor in all.
6 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002025: Rigid Gas Permeable Contact Lens, Polymer Technology (2000) Summary page 2.

## Most influential descendants
- K180988: Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lens, Acuity 58 (enflufocon B) Rigid Gas Permeable Contact Lens, Acuity 85 (Oprifocon A) Rigid Gas Permeable Contact Lens, Acuity 100 (hexafocon A) Rigid Gas Permeable Contact Lens (2018), 5 descendants of its own
- K230965: Acuity 100™ (hexafocon A) with Tangible™ Hydra-PEG®, TYRO™-97 (hofocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lens (2023), 4 descendants of its own
- K240618: Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100™ (hexafocon A) Rigid Gas Permeable Contact Lens; Acuity 200™ with Tangible® Hydra-PEG® (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100™ with Tangible® Hydra-PEG® (hexafocon A) Rigid Gas Permeable Contact Lens (2024), 3 descendants of its own
- K242393: Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lenses (2024), 0 descendants of its own
- K241398: SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses (2024), 0 descendants of its own

## Indications for use
BOSTON XO (hexafocon A), BOSTON EO (enflufocon B), BOSTON ES (enflufocon A), BOSTON 7 (satafocon A), and BOSTON RXD (itabisfluorofocon A RGP Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, astigmatism, and presbyopia) in aphakic and not-aphakic persons with non-diseased eyes. The lens may be disinfected using a chemical disinfecting system only. BOSTON IV(itafocon B), BOSTON II(itafocon A)RGP Contact Lenses are indicated for daily wear for the correction of visual acuity for non-aphakic persons with myopia, hyperopia, or keratoconus and for the correction of corneal astigmatism up to 4.00 diopters. The lens is disinfected using a chemical (not heat) disinfection system recommended in the labeling.

Source page: https://510kreport.com/device/K073184
Methodology: https://510kreport.com/methodology