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Sapphire S415

by Omm Imports Inc.

Sapphire S415 is a blue-light phototherapy lamp (FDA Class II; FDA product code OLP, Over-The-Counter Powered Light Based Laser For Acne) made by Omm Imports Inc., listed in FDA GUDID since 24 Jun 2022 (UDI-DI 00850001456029), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850001456029 UDI-DI Date24 Jun 2022ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
Sapphire
Generic name
Blue-light phototherapy lamp, home-use
Model / reference
S415
Primary DI / UDI-DI
00850001456029
FDA product code
OLP
GMDN term
Blue-light phototherapy lamp, home-use
Device class
Class II
Regulation number
878.4810
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

Related devices

Category: Blue-light phototherapy lamp, home-use

Similar devices

Other devices filed under FDA product code OLP (Over-The-Counter Powered Light Based Laser For Acne).

Other devices from Omm Imports Inc.

See all devices from Omm Imports Inc. →

Properties

  • Contains latex
  • Over-the-counter
  • Manufacturing date
Other properties (12, all answered No)