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Edge Guide Tip 800 Tip

by Jeisys Medical Incorporated

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08800020109712 UDI-DI Date16 Jul 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Edge Guide Tip
Generic Name
Dermatological carbon dioxide laser system
Model / Reference
800 Tip
Primary DI / UDI-DI
08800020109712
510(k) Number
FDA Product Code
ONG, GEX
GMDN Term
Dermatological carbon dioxide laser system
Device Class
Class II
Regulation Number
878.4810
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K162169)

Show all (11)

Other devices from Jeisys Medical Incorporated

See all devices from Jeisys Medical Incorporated →

Properties

  • Lot / Batch Number
  • Manufacturing Date

Other properties (12)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No