BostonSight Scleral— 510(k) K183175
Substantially EquivalentBostonsight
FDA 510(k) clearance K183175 for BostonSight Scleral, Substantially Equivalent on 2019-01-04. Applicant: Bostonsight. Device class: 2.
Clearance details
- Applicant
- Bostonsight
- Product code
- Code HQD
- Device class
- Class 2
- Regulation
- 21 CFR 886.5916
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Needham, MA, US
Recent devices under product code HQD
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- K242393 — Acuity 181 (tisilfocon A) and Acuity 181 (tisilfocon A) with Tangible Hydra-PEG® Rigid Gas Permeable Contact Lenses
- K241398 — SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses
- K241571 — BostonSight® Specialty Lenses
- K240618 — Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact Lens +3 more
More clearances from Bostonsight
view allRecalls naming K183175
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K183175.
Data sourced from openFDA. This site is unofficial and independent of the FDA.