Chrysalis Intelligence · Product Codes · ORZ

ORZ · Unclassified

6 clearances · 3 unique sponsors

Device class
Regulation —
Total clearances
6
2020-05-21 → 2026-04-27
Last 12 months
1
Unique sponsors
3
Medical specialty
Review panel
Regulation number
Implant
Life-sustain / support
GMP exempt
Third-party review
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Sight Sciences, Inc. 4 1 2026-04-27
Novoxel , Ltd. 1 0 2024-11-04
Tear Film Innovations, Inc. 1 0 2020-05-21
Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

CodeTypeDescriptionConfidenceRationale
67801 CPT Medium Eyelid thermotherapy or thermal pulsation treatment for meibomian gland dysfunction
92004 CPT Low Comprehensive eye exam; may be paired with therapeutic eyelid treatment
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-04-27 K252409 Sight Sciences, Inc. TearCare MGX System
2025-04-15 K242786 Sight Sciences, Inc. TearCare MGX System
2024-11-04 K240512 Novoxel , Ltd. Tixel i (TXLI0001)
2023-12-27 K231084 Sight Sciences, Inc. TearCare MGX System
2021-12-21 K213045 Sight Sciences, Inc. TearCare System
2020-05-21 K200400 Tear Film Innovations, Inc. Systane iLux2