Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Surgilase, Inc. — Predicate Candidate Screening

19 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

83 daysmedian FDA review time
200 days90th percentile
19clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K932421SURGILASE/OP 15, 20, 25, 30, 40, 50 CO2 SURG. LASESurgilase, Inc.1993-10-151490
K924664SURGILASE FIBERLASE CO2 LASER WAVEGUIDESurgilase, Inc.1993-04-152260
K905006SURGILASE SL 150 SURGICAL LASER SYSTEMSurgilase, Inc.1991-02-211070
K904203SURGILASE SL 50/60 GOLD SURGICAL LASER SYSTEMSurgilase, Inc.1990-12-07860
K902211SURGILASE YAG 100 SURGICAL LASER SYSTEMSurgilase, Inc.1990-06-29500
K900570SURGILASE YAG 100 IN ORTHOPEDIC SURGERYSurgilase, Inc.1990-05-01830
K901227SURGILASE CO2 SURGICAL LASER SYSTEMS MODEL SL120Surgilase, Inc.1990-04-26430
K901211SURGILASE SL50 SURGICAL LASER SYSTEMSurgilase, Inc.1990-04-26430
K894471SURGIPROBES AND SURGISCALPES IN HEAD/NECK SURGERYSurgilase, Inc.1989-11-141190
K894396SURGILASE 25, 40, 45, 55, 60, 80, 100 LASERSurgilase, Inc.1989-08-07210
K891461SURGILASE YAG 100 SURGICAL ND:YAG LASER/GEN SURGSurgilase, Inc.1989-04-06220
K884182SURGILASE YAG 100 SURGIPROBES & SURGISCALPELSurgilase, Inc.1989-01-241180
K884311MODEL SL60 SURGILASE CO2 SURGICAL LASER SYSTEMSSurgilase, Inc.1988-10-27140
K884313MODEL SL45 SURGILASE CO2 SURGICAL LASER SYSTEMSSurgilase, Inc.1988-10-27140
K884092SURGILASE CO2 SURGICAL LASER SYSTEM MODEL SL80Surgilase, Inc.1988-10-13150
K875042ND:YAG 100 SURGICAL LASER FOR NEURO & PULMONARYSurgilase, Inc.1988-06-242000
K881499SURGILASE YAG 100 FOR GYNECOLOGY USESurgilase, Inc.1988-04-29380
K875039ND:YAG 100 SURGICAL LASER FOR GASTRO. AND UROLOGYSurgilase, Inc.1988-04-131280
K852470SURGILASE 40SSurgilase, Inc.1985-11-131550

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda